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Yahoo
4 days ago
- Business
- Yahoo
Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity
The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launch of emerging therapies such as Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), and others, heightened UV exposure, advancements in diagnostic techniques, and lifestyle changes. New York, USA, July 22, 2025 (GLOBE NEWSWIRE) -- Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity | DelveInsight The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launch of emerging therapies such as Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), and others, heightened UV exposure, advancements in diagnostic techniques, and lifestyle changes. DelveInsight's Melanoma Market Insights report includes a comprehensive understanding of current treatment practices, emerging melanoma drugs, market share of individual therapies, and current and forecasted Melanoma market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Melanoma Market Report According to DelveInsight's analysis, the total melanoma market size is expected to grow positively by 2034. The United States accounts for the largest market size of melanoma, in comparison to EU4 (Germany, Italy, France, and Spain) and the UK, and Japan. In 2024, the total number of incident cases of melanoma was approximately 105K in the US. The trend indicates that melanoma occurs more frequently in males than in females, and around 20% of cases eventually progress to advanced stages (stage III/IV), involving unresectable or distant metastatic disease. Prominent companies, including Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others, are actively working on innovative melanoma drugs. Some of the key melanoma therapies in the pipeline include Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab, and others. These novel melanoma therapies are anticipated to enter the melanoma market in the forecast period and are expected to change the market. In May 2025, Immatics announced the presentation of expanded data from the ongoing Phase Ib clinical trial evaluating IMA203 in heavily pretreated patients with metastatic melanoma In April 2025, IDEAYA Biosciences announced a successful FDA Type D meeting on the Phase III registrational trial design that would assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma. Discover which melanoma medications are expected to grab the market share @ Melanoma Market Report Melanoma Overview Melanoma is a type of skin cancer that originates in melanocytes, the pigment-producing cells responsible for giving skin its color. While it is less common than other skin cancers, melanoma is significantly more aggressive and has a higher risk of spreading to other parts of the body if not detected early. It can occur anywhere on the body but is most frequently found on areas exposed to the sun, such as the back, legs, arms, and face. The primary cause of melanoma is ultraviolet radiation from sunlight or artificial sources like tanning beds, which can damage the DNA in skin cells. Individuals with fair skin, a history of sunburns, a large number of moles, or a family history of melanoma are at higher risk. Genetic mutations, such as in the BRAF gene, also play a significant role in the development of melanoma in certain cases. Symptoms of melanoma often begin with changes in the appearance of a mole or pigmented area. Warning signs include asymmetry, irregular borders, color variation, a diameter larger than 6 mm, and evolving shape or size, summarized by the ABCDE rule. Itching, bleeding, or the appearance of a new mole can also be concerning signs. Diagnosis typically involves a thorough skin examination followed by a biopsy of any suspicious lesion. If melanoma is confirmed, further tests such as sentinel lymph node biopsy, imaging scans (CT, MRI, or PET), and blood work may be conducted to determine the stage and whether the cancer has spread. Early diagnosis is critical, as it significantly improves the prognosis and expands treatment Epidemiology Segmentation The melanoma epidemiology section provides insights into the historical and current melanoma patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The melanoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Melanoma Stage-specific Incident Cases of Melanoma Mutation-specific Incident Cases of Melanoma Line-wise Treated Cases of Melanoma Download the report to understand which factors are driving melanoma epidemiology trends @ Melanoma Treatment Algorithm Melanoma Treatment Market There remains a substantial unmet need for effective treatment options in melanoma patients who are resistant to, unsuitable for, or unresponsive to standard therapies like checkpoint inhibitors or BRAF/MEK-targeted treatments. The FDA has approved several therapies for melanoma, including AMTAGVI (lifileucel, Iovance Biotherapeutics), OPDUALAG (nivolumab + relatlimab, Bristol Myers Squibb), KEYTRUDA (pembrolizumab, Merck), OPDIVO (nivolumab, BMS), KIMMTRAK (tebentafusp-tebn, Immunocore), YERVOY (ipilimumab, BMS), TECENTRIQ (atezolizumab, Roche), among others. AMTAGVI, from Iovance Biotherapeutics, became the first FDA-approved, personalized, one-time T cell therapy in February 2024. It is intended for adults with unresectable or metastatic melanoma who have previously been treated with PD-1 inhibitors, and for those with BRAF V600 mutations, after BRAF inhibitor ± MEK inhibitor therapy. That same year, Iovance submitted a Marketing Authorization Application (MAA) for lifileucel to the EMA in June (validated in August) and to the UK's MHRA in October. In June 2025, Iovance announced that the final results from the Phase II C-144-01 trial of AMTAGVI in advanced melanoma patients were published in the Journal of Clinical Oncology and presented at the 2025 ASCO Annual Meeting. Bristol Myers Squibb's OPDUALAG combines nivolumab, a PD-1 inhibitor, with relatlimab, a LAG-3 inhibitor, and is indicated for the treatment of unresectable or metastatic melanoma. The FDA approved it in March 2022 for adults and children aged 12 and above. However, in February 2025, BMS reported that the Phase III RELATIVITY-098 trial did not achieve its primary endpoint of recurrence-free survival (RFS) in the adjuvant setting for completely resected stage III–IV melanoma, although the safety profile remained consistent with existing data on the combination. KEYTRUDA and OPDIVO both demonstrate strong efficacy in treating melanoma, though OPDIVO has gained greater commercial traction through effective combination regimens and broader clinical use. Despite metastatic melanoma often being incurable, the emergence of advanced treatments such as immune checkpoint inhibitors and targeted therapies has markedly improved survival and quality of life, signaling a significant evolution in the standard of care. Learn more about the melanoma treatment options @ Melanoma Treatment Guidelines Melanoma Emerging Drugs and Companies Some of the products in the pipeline include Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), RP1 (vusolimogene oderparepvec) plus nivolumab (Replimune and BMS), APG-115 (Ascentage Pharma), Naporafenib (ERAS-254) (Erasca), KB707 (Krystal Biotech), Darovasertib (IDE196) (IDEAYA Biosciences and Novartis), HBI-8000 (HUYA Bioscience and BMS), Fianlimab (Regeneron Pharmaceuticals), and others. IMA203 is a TCR T-cell therapy that targets the Preferentially Expressed Antigen in Melanoma (PRAME). It's designed to identify an intracellular PRAME-derived peptide displayed on the surface of cells by HLA-A*02:01, triggering a strong and specific anti-tumor immune response. Encouraging Phase Ib results, along with PRAME's high expression rate in melanoma (~90–95%), support IMA203's therapeutic promise. The therapy is currently under investigation in the SUPRAME Phase III trial (NCT06743126) for previously treated advanced or metastatic cutaneous melanoma, and its Phase Ib expansion now includes uveal melanoma. According to the company's 2024 Annual Report, interim analysis for IMA203 is expected in Q1 2026, with final Phase III results in Q4 2026. A Biologics License Application (BLA) submission is planned for Q1 2027, aiming for a market launch in Q3 2027. RP1 is a herpes simplex virus-based therapy modified with a fusogenic protein (GALV-GP R) and GM-CSF to enhance tumor cell destruction, increase immunogenic cell death, and promote a systemic anti-tumor immune response. The FDA has awarded Breakthrough Therapy Designation (BTD) for RP1 in combination with nivolumab for adults with advanced melanoma that has progressed after anti-PD1 treatment. In June 2025, Replimune shared updated results from the IGNYTE study (RP1 + nivolumab in anti-PD1-refractory melanoma) at the 2025 ASCO Annual Meeting. Darovasertib (IDE196) is a potent, selective PKC inhibitor in clinical development. PKC lies downstream of the GNAQ and GNA11 pathways. Darovasertib is currently in a Phase III trial for primary non-metastatic uveal melanoma, a Phase II/III (DAR-UM-2) study for HLA-A2-negative metastatic uveal melanoma (MUM), and other Phase II trials in ocular melanoma. The company expects results from the pivotal DAR-UM-2 trial in first-line HLA-A2-negative MUM by late 2025. In March 2025, the FDA granted BTD to darovasertib for neoadjuvant treatment of primary uveal melanoma patients recommended for enucleation. The anticipated launch of these emerging melanoma therapies are poised to transform the Melanoma market landscape in the coming years. As these cutting-edge melanoma therapies continue to mature and gain regulatory approval, they are expected to reshape the melanoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about new treatment for melanoma, visit @ Melanoma Management Melanoma Market Dynamics The melanoma market dynamics are anticipated to change in the coming years. Drugs like OPDIVO and KEYTRUDA, particularly in combination with ipilimumab, have significantly improved overall survival and achieved durable response rates (~30–40%) in metastatic melanoma; however, the limited long-term efficacy in many patients highlights the urgent need for effective second-line therapies and continued innovation. With nearly 50% of melanoma patients harboring BRAF mutations, targeted therapy has become a viable option, while molecular profiling enables patient stratification even in refractory settings for clinical trials and off-label interventions. Moreover, targeting underrepresented melanoma subtypes such as uveal, mucosal, and acral presents opportunities for market expansion and accelerated regulatory pathways, given the high unmet need and paucity of existing therapies. Furthermore, many potential therapies are being investigated for the treatment of melanoma, and it is safe to predict that the treatment space will significantly impact the melanoma market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the melanoma market in the 7MM. However, several factors may impede the growth of the melanoma market. Moreover, melanoma treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the melanoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the melanoma market growth. Melanoma Report Metrics Details Study Period 2020–2034 Melanoma Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Melanoma Companies Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others Key Melanoma Therapies Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab, and others Scope of the Melanoma Market Report Melanoma Therapeutic Assessment: Melanoma current marketed and emerging therapies Melanoma Market Dynamics: Conjoint Analysis of Emerging Melanoma Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Melanoma Market Access and Reimbursement Discover more about melanoma drugs in development @ Melanoma Clinical Trials Table of Contents 1. Melanoma Market Key Insights 2. Melanoma Market Report Introduction 3. Melanoma Market Overview at a Glance 4. Melanoma Market Executive Summary 5. Disease Background and Overview 6. Melanoma Treatment and Management 7. Melanoma Epidemiology and Patient Population 8. Patient Journey 9. Melanoma Marketed Drugs 10. Melanoma Emerging Drugs 11. Seven Major Melanoma Market Analysis 12. Melanoma Market Outlook 13. Potential of Current and Emerging Therapies 14. KOL Views 15. Unmet Needs 16. SWOT Analysis Related Reports Melanoma Pipeline Melanoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key melanoma companies, including IO Biotech, Moderna Inc., Merck Sharp & Dohme LLC, BioNTech SE, TILT Biotherapeutics LLC, Nykode Therapeutics, Achilles Therapeutics UK Limited, Evaxion Biotech, InxMed, AiVita Biomedical, Cytovation AS, Ono Pharmaceuticals, Neon Therapeutics, Iovance Biotherapeutics, among others. Ocular Melanoma Market Ocular Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ocular melanoma companies, including Bristol Myers Squibb, Merck & Co., Inc., Novartis AG, Roche Holding AG, Pfizer Inc., AstraZeneca PLC, Eli Lilly and Company, Bayer AG, GlaxoSmithKline PLC, Amgen Inc., among others. Uveal Melanoma Market Uveal Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key uveal melanoma companies, including Novartis Pharmaceuticals, Foghorn Therapeutics, TriSalus Life Sciences, Inc., Bristol Myers Squibb, Array BioPharma, Ono Pharmaceutical, AstraZeneca, Roche, IDEAYA Biosciences, Merck & Co, GlaxoSmithKline, Janssen, among others. Metastatic Melanoma Market Metastatic Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic melanoma companies, including Cancer Insight LLC, Elios Therapeutics LLC, Evaxion Biotech A/S, Merck Sharp & Dohme LLC, Novartis Pharmaceuticals, InxMed (Shanghai) Co. Ltd., Aivita Biomedical Inc., Hoffmann-La Roche, Idera Pharmaceuticals, Iovance Biotherapeutics Inc., Eisai Inc., Biocad, Myrexis Inc., Pain Therapeutics, Altor BioScience, among others. Refractory Metastatic Melanoma Market Refractory Metastatic Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key refractory metastatic melanoma companies, including BioNTech SE, Y-mAbs Therapeutics, Seagen Inc., among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. 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CTV News
5 days ago
- Health
- CTV News
‘Mole Mobile' stops in North Bay to offer skin cancer screening
A mobile melanoma cancer clinic pulled into North Bay on Thursday morning and will be back in action there again Friday. A mobile melanoma cancer clinic pulled into North Bay on Thursday morning and will be back in action there again Friday, where a doctor screens people for skin cancer. 'Mole Mobile' is visiting major Canadian cities with long wait times to see a dermatologist and underserved communities to help speed up diagnosis. Mole main A mobile melanoma cancer clinic pulled into North Bay on Thursday morning and will be back in action there again Friday, where a doctor screens people for skin cancer. (Eric Taschner/CTV News) Dermatologist Dr. Michael Connolly is helping Melanoma Canada by screening patients by checking for melanoma inside the mobile unit. 'This type of service should be more available to patients,' Connolly said. Melanoma and skin cancer rates have been increasing across the globe. Incidence rates for new melanoma cases have been rising on average by 1.4 per cent each year over the last 10 years. When examining patients, Connolly examines what he describes as the 'ABCs' of melanoma -- asymmetry, border, colour, diametre and evolving. These characteristics help health-care professionals recognize suspicious moles or lesions that may warrant further examination. Common type of cancer 'We check not only for melanoma, but we check for non-melanoma skin cancers, too,' Connolly said. 'Like basal cells, squamous cells and for pre-cancerous lesions.' Skin cancers are the most common type of cancer diagnosed in men older than 49 and are among the most common cancers diagnosed in youth and young adults. If detected early, melanoma and skin cancers are largely treatable. Colleen Piekarski Colleen Piekarski knows the importance of getting checked all too well. In 2013, she discovered a bump on her scalp, which turned out to be Stage 3 melanoma. (Eric Taschner/CTV News) Colleen Piekarski knows the importance of getting checked all too well. In 2013, she discovered a bump on her scalp, which turned out to be Stage 3 melanoma. Piekarski's biopsy results were serious. She had immediate head and neck surgery, where a two-inch circle of her scalp and 14 lymph nodes were removed. She then underwent intense rounds of radiation. She started a drug trial, which was unsuccessful, and she was urgently switched to another trial at Princess Margaret Hospital. After eight weeks of initial treatment, the response was going well. So, she continued to receive treatment every two weeks in Toronto for the next six months before she was able to ring the bell in 2015. Ten years later, she's cancer-free but still follows recommendations to wear a wide-brimmed hat and sunscreen when outdoors. 'It's not a little skin cancer on the surface of your skin. It is deep and it can get into your lymph nodes and into your bloodstream and it can move,' she said. Mole Mobile 'Mole Mobile' is visiting major Canadian cities with long wait times to see a dermatologist and underserved communities to help speed up diagnosis. (Eric Taschner/CTV News) She, along with her son Christopher, have organized walks for melanoma awareness in North Bay. She said she's happy knowing others are getting screened. Piekarski plans to even go to the Mole Mobile with her daughter for a quick followup. 'I think it's super important,' she said. During Melanoma Canada's last Mole Mobile tour in Ontario, more than 2,200 people were screened at 30 stops. Among them, dermatologists identified 56 potential melanomas, 148 suspected basal cell carcinomas and 36 possible cutaneous squamous cell carcinomas. The Mole Mobile will be set up Friday at Sunset Park (across from Perreault's Prime Time Ice Fishing) from 10 a.m. until 4 p.m. in North Bay. On Saturday, it will be in Sudbury at Bell Park, in the York Street South Parking Lot, from 10 a.m. until 4 p.m. On Sunday, it will be in Parry Sound at Canadian Tire, 30 Pine Dr., from 10 a.m. until 4 p.m. No appointment is needed and the free skin check will be performed by a certified dermatologist.
ABC News
6 days ago
- Health
- ABC News
The 'difficult' phase of returning to life after cancer treatment
In December, Grace Passfield finished four years of immunotherapy for metastatic melanoma. "I was really lucky, I had a really good response to that," says the 37-year-old physiotherapist and mother-of-two from Newcastle/Awabakal. "I had a scan at six weeks after starting the immunotherapy and all the melanoma had stopped growing, and then I had another scan six weeks later and half of it had gone or had shrunk significantly." When the time came to stop the treatment, Grace says many people close to her assumed she would be thrilled to return to "normal life". "Everyone was very excited that I was finishing and saying things like 'it's just so wonderful you're finishing, that's amazing'," she says. "But I was quite terrified because [treatment] felt like a safety net, it felt like a security blanket. "I had my last treatment, and I cried for half of the session." Clinical psychologist Samantha Clutton specialises in oncology support on Kabi Kabi lands on the Sunshine Coast. "It's a really difficult phase," she says. "A lot of people believe that once they sort of recover from the initial shock of diagnosis and get through the physical and psychological challenges of treatment, that they will feel better, that it will all be over. "And yet … particularly those months following the end of treatment, [it] is a very difficult time." Grace says once she realised her mortality, she couldn't "unsee it". Despite her treatment being deemed successful, she battles with constant anxiety that the disease will return. "Any sort of persistent niggles or pain" brings up that worry. "I have contact with my psychologist regularly … when I start to get worried about the future, she talks about how that's just a story and try to focus on what's going on right now." She says regular self-care and exercise are an important part of that. Grace still has routine scans, which look for signs of the disease. "I've had it described [as] it's almost like living with a chronic disease and that you're always monitoring for it," she says. The CEO of Cancer Australia, Professor Dorothy Keefe, says "survivorship care" is important and having a plan for that is key for people. "So that they know what sort of tests should be done, how often, and what to do if there's a crisis," the oncologist and supportive care expert says. "I would always say to my patients, this is something that could potentially come back, but it doesn't always come back. "And although we don't know if you in particular are cured at this point, there's no reason it shouldn't be you, so let's be positive, let's live life." Professor Keefe says it can be helpful to keep a check on anxiety levels. "Are they able to manage their normal activities of daily living?" she says. "Are they socialising? She says everybody's different and will need different levels of support. Ms Clutton says getting professional support can help normalise any challenging feelings. "People will very often feel as if there's something wrong with them because they're not feeling great," she says. "They don't have a renewed sense of purpose necessarily, they're not feeling incredibly grateful all of the time moving forward. "So, helping people to understand that this is a really normal reaction can really help to lift that layer of stress." She says Cancer Council Australia can direct people to either to their service or to other services within hospitals or other cancer organisations that can offer free or no out-of-pocket cost services. Grace, who returned to work as a physiotherapist several years ago, says while she had an amazing support system during her treatment, some of that has waned. "I said to my psychologist, 'How lucky am I? Everyone's so amazing'," she says "And she said, 'that will drop off and people do forget', and that did happen. Ms Clutton says she recommends people "check with their loved ones who have finished cancer treatment and don't assume that they're doing well". "Ask them how they're feeling and really stop and try and listen and reflect an understanding of that person's experience rather than trying to shut them down or tell them that they need to think positively." This is general information only. For personal advice, you should see a qualified medical practitioner.
Medscape
6 days ago
- Business
- Medscape
FDA Declines to Approve New Melanoma Therapy
The FDA has declined to approve a new oncolytic immunotherapy, vusolimogene oderparepvec (RP1), to treat advanced melanoma. The agency recently issued a complete response letter to the company, Replimune Group, rejecting its biologics license application that sought approval for the new agent in combination with nivolumab (Opdivo) to treat adults with advanced melanoma. In the complete response letter, the FDA indicated that it can't approve the biologics license application for vusolimogene oderparepvec because the company's IGNYTE trial 'is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness,' Replimune explained in a press release. According to Replimune, the complete response letter also noted that the trial data 'cannot be adequately interpreted due to the heterogeneity of the patient population,' and that 'there are items related to the confirmatory trial study design which need to be addressed.' 'We are surprised by the FDA decision and disappointed for advanced melanoma patients who have limited treatment options, as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data,' stated Sushil Patel, PhD, Replimune's chief executive officer. Vusolimogene oderparepvec is the lead product candidate for the biotech company. Patel further noted that the issues raised in the complete response letter were not 'raised by the agency in mid- and late-cycle reviews.' Additionally, he said, 'we had also aligned on the design of the confirmatory study.' The FDA's response to the biologics license application for the new agent, along with its recently announced policy requiring randomized, controlled trials for approval of COVID vaccines in healthy Americans younger than 65 years, may signal that the agency is taking a tougher stance on new drug approvals. Replimune plans to 'urgently interact with the FDA to find a path forward for the timely accelerated approval of RP1,' according to its statement. Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape Medical News, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@ or on X @SW_MedReporter.
Times
7 days ago
- Entertainment
- Times
Feel the burn: Ulrika Jonsson's tan has become a hot topic
It was when I saw on my daughter's Instagram feed a video that suggested changing the name of toasters to 'sunbeds for bread', in which young women admired golden slices of toast as an ideal facial aesthetic, that I knew something very strange had happened in the world of tanning. This isn't just a fad, it's a burning issue. Ulrika Jonsson, the TV presenter, has posted on her Instagram account to address unkind comments about her recent appearance. Jonsson was seen on YouTube with a deep tan, around Yorkshire Tea on the Trump tan tint colour swatch. To achieve this with her fair Scandinavian genotype she has to put in the hours. Not only does Jonsson use sunbeds in winter, she wrote, but she likes the sun on her skin in summer. 'I'm not ashamed to say that I am a sun worshipper,' Jonsson wrote. 'And will no doubt pay the price for that.' Jonsson, 57, was receiving flak for the ageing effect this has on her face. 'I understand that an over-tanned, imperfect and AGEING face offends you,' she wrote. But in terms of her joyful dedication to solar radiation, she was in fact ageing in reverse. Generation Z girls have ditched the safe fake tan of their mothers and joined an ancient and dangerous sun cult whose last-known practitioners died out in the 1980s, embalmed in Hawaiian Tropic. Ulrika Jonsson Sunbed use is on the rise, sunbathing is on the rise, melanomas are on the rise, the whole package holiday. If you need any convincing, ask a teenage or early twentysomething girl what the UV index is. I'll wait. My life had been utterly untroubled by the UV index. In fact I hadn't even noticed when it appeared on the weather forecast in the early 2000s. It was put there to warn the public of the days when the sun's rays were at their most carcinogenic. Now the British UV index is as old as the only people who obsess on it: young women. But in a development that is in some respects quite funny, they have weaponised it for evil. For Gen Z girls, the UV index is an unholy tool in which good is bad and bad is good. TikTok is now full of videos — some deadly serious, some satirical — about the need to intently track the UV index 'like it is the stock market and you are a day trader'. When the UV index reaches a ten, meaning there is a high risk of burning for white skin, the videos show girls cheering and running outdoors in their bikinis. Fake tan is deemed such an inferior substitute that girls apply it while wearing swimwear, carefully taping off the lines of their bikinis to make sure no one would guess they are doing anything the safe way. What does it mean? In the 1960s young people innocently sacrificed their health to big tobacco because smoking was cool. Same as in the 1980s, when I tanned to burn, rotating on my beach towel like a doner kebab. Yet now we know the risks, doing it anyway becomes more interesting. Sunburn is more carcinogenic the younger it hits. Skin cancer is now the third most common cancer among British women aged 15 to 44, according to Cancer Research UK. Melanoma is 2.6 times higher in women aged 20 to 24 than in men in the same age range. A long-term study on nurses published in Cancer Epidemiology in 2014 found that five bad sunburns between the age of 15 and 20 increased risk of melanoma by 80 per cent. Yet the UK's biggest tanning chain, the Tanning Shop, has increased its number of premises by almost 40 per cent since 2018. • The best self-tanners for summer 2025 — and how to apply them You don't need me to tell you all this. The evidence is clear and I'm not your mother. I am, however, a mother to a teenage girl. I am a regretful and reformed factor 50 zealot who creeps around in the shadows. Her friends, meanwhile, live in the light. I remind her that I am the wrinkled ghost — complete with a spooky white sunblock mask — of Christmas future. Her generation remind me of many things. Teenagers are designed to rebel: see the TikTok video of a teenage girl with a huge smile, captioned 'how it feels to tan when there's no rat in my ear telling me I'm going to get skin cancer' (to be clear, I'm the rat). Smoking remained cool for young people in the 1980s even when we had full knowledge of the risks. All the warnings targeted at young people missed the point. It wasn't cool despite the risks, it was cool because of the risks. Telling teens that smoking was dangerous was its best advert. And in a similar vein to big tobacco, we now have big sun: smoking's wizened brown lungs have been swapped out for wizened brown skin. Same for lectures from tan-phobic parents like me: they are all part of tanning's appeal. Tanning, like smoking before it, provides an addictive hit of youthful invincibility, like drugs or fast motorbikes. If you're neither going to die nor get old, why worry about wrinkles? Gen Z's tanning and ever-younger use of anti-ageing treatments such as Botox seems strangely contradictory. Yet in practice it is consistent. It's about looking good now. Those tanorexic elderly nudists with bits like beef jerky are of no relevance to them. • A 2022 study in the journal Genes asked nearly 4,000 white British 25-year-olds about tanning. More than half said they 'liked to tan', with 90 per cent saying their favourite way was outdoors in the sun. Their top three reasons were in descending order 'it makes you happier', 'it gives you more confidence' and 'it makes you look better in photos'. Looking 'thinner with a tan' came in at number five. Only a fifth said they had not had a painful sunburn lasting a day or more in the last two years. In the US mainstream politics is more into sunning itself. Donald Trump has so far remained silent on how he achieves his trademark skin tone. A White House official said in 2019 that it was the result of 'good genes'. But Unhinged, a memoir by the former White House aide Omarosa Manigault Newman, claimed that Trump had a tanning bed in the White House. Robert F Kennedy Jr, America's mahogany health secretary, believes in tanning. He was photographed leaving a Washington DC tanning salon last month. His plan to 'Make America Healthy Again', released in May, is unusual in not mentioning sunburn, one of the major lifestyle factors causing the rise in young people's cancer. Instead, in October Kennedy tweeted that the US Food and Drug Administration's 'aggressive suppression' of 'sunshine' would end under his reign. I'm joking about big sun but, in a way, we do all live in the shadow of big sun — or rather, what feels like an ever hotter sun in our warming planet. 'I'm a solar panel,' one sunbathing young woman joked on social media. This generation of young people are perhaps unique in their gloominess about the long-term future. If measures to cool the planet aren't being taken, why bother taking measures to stop your skin burning? We may all burn one way or another. The Kennedy rhetoric here is appealing: maybe, hopefully, the scientists have it wrong about the dangers of the sun in every way. Or if they don't, if we are all going to fry, why not go down with a beautiful tan that will look great in the photos? 'My name is Christa and I admit it — I'm a lifelong tanorexic' By Christa D'Souza Christa D'Souza CHRISTA D'SOUZA/INSTAGRAM Poor Ulrika. Folks do like to have a go, don't they? It takes a tanorexic to know one and yes, as someone born in 1960, that is what I am. If you were a teen in the Seventies you probably were too. What exacerbated the addiction — because that is probably what it is — is that I was so terribly good at it. Being of mixed heritage (my dad was Indian) I can almost, as it were, get brown under fluorescent light. When I was a teen it was perfectly normal to want one's face to be the same shade of mahogany as one's body. (Hence putting tin foil up one's nostrils and facing the sun on a deckchair for hours.) It could be raining on holiday and I'd be out there by the pool wanting to be darker. You can never be too rich, too thin or too brown; that was the mantra of the Seventies and though I'm not saying I still hold by that, I'm also saying that I suppose it doesn't sound completely nuts. In one way I wish I'd listened to my mother, who told me summer after summer I was ruining my skin (she herself at 82 has peachy skin. In fact a friendly immigration officer in Pakistan once told her she thought I was the mother, rather than the other way round). But in another it's a price I've always been willing to pay. They say you choose your face or your body. Well, it's crystal clear to any observer which way I swing. Absent of a face transplant or some very, very, very expensive surgery I'm always going to look my age (65). Like Ulrika, I was always destined to be the peach kernel rather than the peach, for which I take full responsibility. My children, who both tend to dress like Shackleton on the beach, are always on at me about it. And I've got the whole season to toast slowly: we live part of the year in Greece, which means there's no rush. Soz, but I love the feeling of the sun on my face too much. And though I'll make some token efforts at the beginning of summer to cream up and wear a hat, ten days in I'll be out there bare-backed, just as I was in my teens and twenties. As for the damage I've wreaked over the years from other bad habits … Like I said, poor Ulrika — and she's only 57, miles younger than me! My advice to her is that she does as I do: keep teetotal, attempt to stay in shape and style it out.
