Latest news with #abiraterone
Yahoo
07-07-2025
- Business
- Yahoo
Johnson & Johnson submits application to the European Medicines Agency seeking indication extension of AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations
The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone or prednisolone compared to a current standard of care, abiraterone acetate plus prednisone or prednisolone1 The results demonstrate significant and clinically meaningful benefits of the niraparib and abiraterone acetate plus prednisone or prednisolone regimen in delaying cancer progression and worsening of symptoms1 BEERSE, BELGIUM, July 03, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of an extension of indication application to the European Medicines Agency (EMA) seeking approval of AKEEGA® (niraparib and abiraterone acetate) with prednisone or prednisolone for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and homologous recombination repair (HRR) gene alterations. mHSPC is a form of prostate cancer that has spread to other parts of the body, but still responds to hormone therapy.2 While the treatment landscape has advanced in recent years, almost all patients eventually develop resistance to therapy, and the disease progresses to metastatic castration-resistant prostate cancer (mCRPC) – an aggressive and currently incurable disease stage.3 Over 20 percent of patients with mHSPC have HRR gene alterations, including alterations in BRCA1/2, which have been shown to negatively impact outcomes.4 These patients have an unmet medical need which existing therapies do not address.4 'Despite significant progress in prostate cancer, individuals with HRR gene alterations often face limited treatment options, faster onset of symptoms and poorer outcomes,' said Henar Hevia, Ph.D., Senior Director, EMEA Therapy Area Head, Oncology, Johnson & Johnson Innovative Medicine. 'With this submission to the EMA, we have the opportunity to offer patients with HRR-mutated mHSPC a treatment specifically targeted to the underlying biology of their disease. Pending approval, this niraparib-based combination will help redefine the standard of care for this high-risk population, significantly delaying the time to their cancer progressing. This milestone reflects our commitment to advancing precision medicine in earlier stages of disease.' The submission was supported by data from the Phase 3 AMPLITUDE study (NCT04497844), evaluating the efficacy and safety of niraparib and abiraterone acetate plus prednisone or prednisolone (AAP) for the treatment of patients with mHSPC with HRR gene alterations, versus placebo plus AAP.1,5 The study demonstrated clinically meaningful and statistically significant outcomes in the primary endpoint of radiographic progression-free survival (rPFS), and the key secondary endpoint of time to symptomatic progression (TSP), with an early trend toward improved overall survival (OS) – highlighting the clinical benefits of niraparib and abiraterone acetate plus prednisone or prednisolone in delaying both cancer progression and the worsening of symptoms versus the current standard of care.1 AMPLITUDE is the first study to show the efficacy of combining a poly (ADP-ribose) polymerase (PARP) inhibitor and androgen receptor pathway inhibitor (ARPI) in this patient population.1 The safety profile of niraparib and abiraterone acetate plus prednisone or prednisolone is consistent with that observed in metastatic castration-resistant prostate cancer (mCRPC), for which niraparib and abiraterone acetate is currently approved.1,6 The most common Grade 3/4 adverse events (AEs) with the niraparib combination were anaemia and hypertension; however, treatment discontinuations due to AEs remained low.1 'At Johnson & Johnson, we remain committed to addressing the needs of individual patients by pushing the boundaries of science and innovation to deliver more personalised and effective treatment options at every stage of the prostate cancer journey,' said Charles Drake, M.D., Ph.D., FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, at Johnson & Johnson Innovative Medicine. 'The fixed dose combination of niraparib and abiraterone acetate has already had a positive impact in shifting the treatment paradigm for patients with metastatic castration-resistant prostate cancer, and we now look forward to extending this benefit to those with hormone-sensitive disease.' Results from the AMPLITUDE study were presented as a late-breaking oral presentation (Abstract #LBA5006) at the 2025 American Society of Clinical Oncology Annual Meeting and selected for inclusion in the Best of ASCO and the ASCO Press Programme.1 About AMPLITUDE AMPLITUDE (NCT04497844) is an ongoing, Phase 3, randomised, double-blind, placebo-controlled, international, multicentre study evaluating the efficacy and safety of niraparib and abiraterone acetate in a dual action tablet (DAT) formulation with prednisone plus androgen deprivation therapy (ADT) compared to matching oral placebo/abiraterone acetate in a DAT formulation with prednisone plus ADT in patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic hormone-sensitive prostate cancer (mHSPC).5 The primary endpoint is radiographic progression-free survival (rPFS).5 The study enrolled 696 participants from 32 countries.1 About Niraparib and Abiraterone Acetate This orally administered, dual action tablet (DAT) consists of a combination of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor.5,7 Niraparib combined with abiraterone acetate and given with prednisone or prednisolone was approved in April 2023 in the European Economic Area for the treatment of patients with BRCA-mutated mCRPC6 in whom chemotherapy is not clinically indicated. Niraparib and abiraterone acetate is also approved in the USA, Canada, Switzerland, United Kingdom and many more. Additional marketing authorisation applications are under review across a number of countries globally. In April 2016, Janssen Biotech, Inc. entered into a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GSK in 2019), for exclusive rights to niraparib in prostate cancer.8 About Metastatic Hormone-Sensitive Prostate Cancer Metastatic hormone-sensitive prostate cancer (mHSPC), also known as metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to ADT and has spread to other parts of the body.2 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Biotech, Inc. and Janssen-Cilag, S.A. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of niraparib and abiraterone acetate. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. © Janssen-Cilag International NV 2025. All rights reserved. ### References Attard G et al. Phase 3 AMPLITUDE trial: niraparib and abiraterone acetate plus prednisone for metastatic castration-sensitive prostate cancer patients with alterations in homologous recombination repair genes. 2025 American Society of Clinical Oncology Annual Meeting. 3 June 2025. National Cancer Institute. Hormone-sensitive prostate cancer. Online. Available at: Last accessed June 2025. Last accessed June 2025. Narayan V et al. Treatment Patterns and Survival Outcomes Among Androgen Receptor Pathway Inhibitor-Experienced Patients With Metastatic Castration-Resistant Prostate Cancer. Clinical Genitourinary Cancer. 2024. 22(6):1-14. Olmos D et al. BRCA1/2 and homologous recombination repair alterations in high- and low-volume metastatic hormone-sensitive prostate cancer: prevalence and impact on outcomes. Annals of Oncology. 2025. doi: 10.1016/ A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE). Available at: Last accessed June 2025. Janssen EMEA. Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorisation for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations. Available at: Last accessed June 2025. AKEEGA Summary of Product Characteristics. August 2024. Available at: Last accessed June 2025. Janssen Enters Worldwide Collaboration and License Agreement with TESARO, Inc., for Niraparib in Prostate Cancer. Available at: Last accessed June 2025. CP-526340 July 2025 CONTACT: Media contact: Laura Coughlan lcoughl5@ +358 87 147 9356 Investor contact: Raychel Kruper investor-relations@ in to access your portfolio
Telegraph
30-05-2025
- Health
- Telegraph
Give prostate cancer patients drug that halves risk of death, NHS told
Men with aggressive prostate cancer should be given a drug that halves their risk of death, experts have urged the NHS. British scientists have used AI to identify which men could most benefit from a treatment which is currently denied by the NHS in England. Researchers found that one in four men with high-risk prostate cancer, which has not yet spread, could see their risk of death halved if they were given the hormone treatment abiraterone. The rest could be spared such treatment, which can cause distressing side effects including loss of libido, as well as fatigue and weakness. The drug is routinely offered to men in Scotland and Wales with newly diagnosed high-risk prostate cancer which has not yet spread. However, the NHS refuses to fund it in England, even though it costs just £2.75 a day. As a result, around 8,400 men a year are denied the drug, which is only given to some men with advanced disease. Prostate cancer in numbers The new study shows just how powerful the drug can be if targeted at the right candidates, in conjunction with standard therapy - cutting deaths by half among those with aggressive disease, while slashing the cost to the NHS. Experts said the findings from The Institute of Cancer Research, London, and University College London (UCL) should prompt NHS officials to review the funding of the drug. The results will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting [MUST KEEP] which opens in Chicago on Friday. Abiraterone, discovered in the UK at The Institute of Cancer Research (ICR), works by inhibiting the production of testosterone in all tissues throughout the body, including in the tumour. The new test, developed by Artera Inc,. uses artificial intelligence to study images of tumour samples and pick out features that are invisible to the human eye. It was tested on biopsy images from more than 1,000 men with prostate cancer who were taking part in a major trial. Men were given a score depending on whether their disease was fuelled by male hormones known as androgens. In cases which were fuelled by the hormones - which makes the disease more aggressive - giving men abiraterone cut the risk of death after five years from 17 per cent to 9 per cent. Prostate cancer cases and rates In cases which were not, the risk went from 7 to 4 per cent among those given the drug, which experts said was not statistically or clinically significant. Such men would benefit from standard treatment, which would spare them the side effects which come with abiraterone, experts said. The current research received funding from Artera Inc., UK MRC and Prostate Cancer UK. Professor Nick James, Professor of Prostate and Bladder Cancer Research at The Institute of Cancer Research, London, who co-led the study said that the drug had already been found to have 'spectacular results' for many men. He said the new findings allowed the treatment to be far more narrowly targeted, to pick out those who would respond best, and spare others from side effects. The Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust said access to the life extending drug was currently 'a postcode lottery' despite the fact the drug costs just £2.75 a day. He urged NHS England to fund the drugs. Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, said: 'Abiraterone has been a game changer for treatment of prostate cancer, and I'm proud of the ICR's role in discovering and testing this drug which has extended the lives of so many men. 'Alongside our mission to find smarter, kinder treatments, we must ensure we are matching the right drugs to the right patients. This research, using artificial intelligence, provides an innovative route to testing prostate cancer patients to determine their treatment. I hope that this can be implemented so that all men with prostate cancer who will benefit from abiraterone can do so.' Study co-leader Professor Gert Attard, at the UCL Cancer Institute said advanced and aggressive prostate cancer could take a 'highly variable' path, with the new evidence showing how algorithms could extract information from routinely available pathology slides to tailor these treatments to specific patients. Dr Matthew Hobbs, Director of Research at Prostate Cancer UK, said: 'Prostate Cancer UK has been calling on the UK Government to approve this life-saving, cost-effective drug for over two years. These exciting results suggest a way to make this an even more cost-effective approach. We therefore echo the researchers' urgent call for abiraterone to be made available to those men whose lives it can save – men who, thanks to this research, we can now identify more precisely than ever before.' 'Treatment has cost me £20,000 so far' Giles Turner, 64, who lives in Brighton, was diagnosed with prostate cancer in March 2023. He has been taking abiraterone for almost two years and has spent £20,000 on his treatment so far. He said: 'This is great research and adds even more reason for NHS England to start funding this treatment now. 'I find it very difficult to come to terms with having to pay for this treatment whereas if I was with the NHS in Scotland or Wales I would not. 'Even more importantly are the thousands of men in England who are missing out on this cheap, life-saving and cost-saving drug. Action must be taken by NHS England and DHSC right now.'
Daily Mail
29-05-2025
- Health
- Daily Mail
AI test could help to cut the risk of dying from prostate cancer by half, study suggests
A revolutionary AI test can help slash the risk of dying from prostate cancer by up to half, a breakthrough study suggests. From examining images of tumours it was able to identify patients who could benefit from a 'game-changer' drug by picking out features invisible to the human eye. Around one in four men with 'high-risk' prostate cancer were found to have a particular biomarker that made them more receptive to the treatment. Among those with the biomarker, taking the drug abiraterone alongside standard hormone therapy cut the risk of death after five years from 17 per cent to 9 per cent – a reduction of 47 per cent. Men without the biomarker saw their risk of death drop from 7 per cent to 4 per cent – which is not thought to be statistically or clinically significant. Abiraterone, which costs just £77 for a month's supply since the patent expired, works by inhibiting the production of testosterone in all tissues throughout the body, including in the tumour. Researchers say NHS England should now make the drug available to the 2,100 men a year who could benefit, while sparing others a treatment that comes with additional side-effects. It is approved for use on the NHS in England for patients with advanced prostate cancer that has come back and spread to other parts of the body, but not for the 8,400 men a year with newly diagnosed high-risk prostate cancer that has not spread. Experts say because fewer men than previously thought will need the drug, NHS England should review the decision not to fund the treatment for those who could benefit earlier. It has been more widely available to men in Scotland and Wales for two years. Scientists from the Institute of Cancer Research (ICR), in London, and University College London examined data from more than 1,000 men whose tumours were at high risk of spreading. The findings, based on a test developed by Artera Inc, will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago. The Mail has campaigned for years to improve the diagnosis and treatment of prostate cancer in a bid to prevent needless deaths. Professor Nick James, who co-led the research at the ICR, said: 'I truly hope this new research – showing precisely who needs the drug to live well for longer – will lead to NHS England reviewing their decision to fund abiraterone for high-risk prostate cancer that has not spread.' An NHS spokesman said: 'Abiraterone continues to be routinely funded by the NHS in England for several forms of advanced prostate cancer in line with clinical guidance, and we are keeping this position under close review.' Meanwhile, lung cancer patients will be offered a new blood test to speed up access to targeted treatments and avoid unnecessary biopsies. The 'liquid biopsy' looks for tiny fragments of tumour DNA and detects mutations. About 15,000 patients a year will benefit, NHS England says.
The Sun
29-05-2025
- Health
- The Sun
‘Game changing' prostate cancer drug that ‘HALVES death risk must be given to thousands more men on the NHS'
THOUSANDS more men should receive an existing prostate cancer drug on the NHS as research shows it could halve their death risk. Scientists say abiraterone could help many more blokes than are currently eligible to receive it under an NHS"postcode lottery". 1 The Institute for Cancer Research in London used artificial intelligence tool to detect biomarkers invisible to the human eye to work out who would benefit. The study found it would benefit one in four patients with high-risk prostate tumours that have not yet spread, equal to around 2,000 men per year in England. They are currently denied access to the drug because health chiefs do not believe it to be cost-effective, although it is available in Scotland and Wales, and for other tumour types in England. It comes after The Sun on Sunday revealed some blokes are paying for their own treatment. Keith ter Braak, 82, from Somerset, said he forks out thousands of pounds per year to buy drugs privately, adding: "Abiraterone keeps me alive. I don't know whether my bank account or my health will last longer." Study leader Professor Nick James, from the ICR, said: "I truly hope that this new research will lead to NHS England reviewing their decision to fund abiraterone for high-risk prostate cancer that has not spread. "Access is currently a postcode lottery, with those living in Scotland and Wales able to receive the treatment for free but the NHS in England deciding it is too expensive. "Since the patent expired in 2022, abiraterone costs just £77 per pack. "My team has shown that preventing cancer relapses for these men would save more money than the drug costs to purchase." Prof James' new study, presented at the conference of the American Society for Clinical Oncology, found that men with a certain tumour biomarker saw their risk of dying within five years slashed from 17 per cent to nine per cent. How to check your prostate cancer risk Three out of four patients did not have the biomarker and saw no significant risk reduction, so would not benefit. Targeting abiraterone specifically at the men identified by the algorithm could save the NHS 75 per cent of its assumed prescription cost. Dr Matthew Hobbs, director of research at Prostate Cancer UK, said: "We have been calling on the Government to approve this life-saving, cost-effective drug for over two years. "These exciting results suggest a way to make this an even more cost-effective approach. "We echo the researchers' urgent call for abiraterone to be made available to those men whose lives it can save." Prof Kristian Helin, chief executive of The Institute of Cancer Research, said the drug has been a "game changer for treatment of prostate cancer". Prostate cancer is the most common form of the disease in men, with 55,000 new cases every year in the UK, and famous patients including former US President Joe Biden, actor Stephen Fry and Olympic cycling legend Chris Hoy. The risk of developing prostate cancer depends on many factors, here are some of the facts about the disease and how many men it affects. One in eight men will get prostate cancer in their lifetime It is the fourth most common cancer worldwide, and the most common in men There are 55,000 new cases every year in the UK, and 1.4million globally Around 12,000 people lose their lives to prostate cancer annually in the UK and almost 400,000 around the world Prostate cancer accounts for 28 per cent of all new cancer cases in men in the UK, and 14 per cent of all new cancer cases in men and women combined Prostate cancer survival has tripled in the last 50 years in the UK More than three-quarters (78 per cent) of patients survive for 10 or more years About 490,000 men are living with and after prostate cancer in the UK It is most common in men aged 75 to 79 Since the early 1990s, cases have increased by 53 per cent in the UK Mortality rates are up 16 per cent since the early 1970s in the UK Incidence rates are projected to rise by 15 per cent in the UK between 2023 to 2025 and 2038 to 2040 Mortality rates are expected to fall five per cent in the UK over the same years
The Guardian
29-05-2025
- Health
- The Guardian
New AI test can predict which men will benefit from prostate cancer drug
Doctors have developed an artificial intelligence tool that can predict which men with prostate cancer will benefit from a drug that halves the risk of dying. Abiraterone has been described as a 'gamechanger' treatment for the disease, which is the most common form of cancer in men in more than 100 countries. It has already helped hundreds of thousands with advanced prostate cancer to live longer. But some countries, including England, have stopped short of offering the 'spectacular' drug more widely to men whose disease has not spread. Now a team from the US, UK and Switzerland have built an AI test that shows which men would most likely benefit from abiraterone. The 'exciting' breakthrough will enable healthcare systems to roll out the drug to more men, and spare others unnecessary treatment. The AI test is being unveiled in Chicago at the annual meeting of the American Society of Clinical Oncology, the world's largest cancer conference. Nick James, professor of prostate and bladder cancer research at the Institute of Cancer Research in London and a consultant clinical oncologist at the Royal Marsden NHS foundation trust, co-led the team that built it. 'Abiraterone has already hugely improved the outlook for hundreds of thousands of men with advanced prostate cancer,' said James. 'We know that for many men with cancer that has not yet spread, it can also have spectacular results. 'But it does come with side-effects and requires additional monitoring for potential issues with high blood pressure or liver abnormalities. It can also slightly increase the risk of diabetes and heart attacks, so knowing who is most likely to benefit is very valuable. 'This research shows that we can pick out the people who will respond best to abiraterone, and those who will do well from standard treatment alone – hormone therapy and radiotherapy.' The test uses AI to study images of tumours and pick out features invisible to the human eye. The team, funded by Prostate Cancer UK, the Medical Research Council and Artera, trialled the test on biopsy images from more than 1,000 men with high-risk prostate cancer that had not spread. The AI test identified the 25% of men in the group most likely to benefit from the abiraterone – for these men, the drug halves the risk of death. In the trial, patients received a score – biomarker-positive or -negative – which was compared with their outcomes. For those with biomarker-positive tumours, one in four of the men, abiraterone cut their risk of death after five years from 17% to 9%. For those with biomarker-negative tumours, abiraterone cut the risk of death from 7% to 4% – a difference that was not statistically or clinically significant, the team said. These men would benefit from standard therapy alone and be spared unnecessary treatment. Sign up to First Edition Our morning email breaks down the key stories of the day, telling you what's happening and why it matters after newsletter promotion The study co-leader Prof Gert Attard, of the UCL Cancer Institute, said: 'This study shows, in a very large cohort of patients, that novel algorithms can be used to extract information from routinely available pathology slides to tailor these treatments to specific patients and minimise over treatment whilst maximising the chance of cure.' James said that because fewer men than previously thought would need the drug, healthcare systems should consider giving it to men whose cancer had not spread. It is approved for NHS use in England for advanced prostate cancer, but not for newly diagnosed high-risk disease that has not spread. However, it has been available for men with this indication in Scotland and Wales for two years. 'Abiraterone costs just £77 per pack, compared with the thousands of pounds that new drugs cost,' said James. 'I truly hope that this new research – showing precisely who needs the drug to live well for longer – will lead to NHS England reviewing their decision not to fund abiraterone for high-risk prostate cancer that has not spread.' Dr Matthew Hobbs, director of research at Prostate Cancer UK, described the AI test as 'exciting'. He added: 'We therefore echo the researchers' urgent call for abiraterone to be made available to those men whose lives it can save – men who, thanks to this research, we can now identify more precisely than ever before.'
