Latest news with #TheLancetOncology
Daily Mail
03-07-2025
- Health
- Daily Mail
Startling discovery about The Pill and cancer that's rising in young people
Thousands of women who take the Pill are not at higher risk of potentially deadly liver cancer, research today suggested. Studies have long suggested there may be a link between the combined oral contraceptive pill and the risk of developing tumours in the liver. This is because the birth control pill contains the hormone oestrogen, which scientists believe can stimulate some cancer cells to grow. But now, in one of the largest studies to date involving more than 1.5million British women, researchers discovered there was 'little to no association' between taking the Pill and liver cancer. Experts, who said the study was the 'most comprehensive to date', concluded there was 'no overall link'. Liver cancer now kills 5,800 people in the UK each year compared with 2,200 in the late 1990s, making it the UKs fastest rising killer and responsible for double the deaths of skin cancer. It's currently the eighth most common cause of cancer death in the UK, but by 2040, the charity warns that it could rank sixth. Cancer Research UK figures also suggest rates of the disease have increased by 86 per cent among 25-to-49-year-olds since the 1990s. In the study, researchers analysed data from 23 previous studies as well as the UK biobank health study involving over a million women. They compared women who had ever used a birth control pill with those who never used them and found there were 5,400 liver cancer cases logged across all studies. Writing in the journal The Lancet Oncology, the researchers said there was 'no association with liver cancer risk'. However, they added, there was 'weak evidence that women who used the birth control pill for longer periods had a very slight increased risk of liver cancer (6 per cent) per 5 years of use.' This they said, was likely to due to unmeasured factors such as patients who had Hepatitis B or C infection—a major risk factor for liver cancer. Around one in four liver cancer cases in the UK are also caused by obesity, while a fifth are related to smoking, and one in 14 are due to excessive alcohol, research shows. Latest NHS figures for suggest there were almost 3million prescriptions for the combined pill and more than 4million for the mini pill, which just contains progestogen. Around a quarter of all women aged 15 to 49 are on either the combined or progesterone only pill. The proportion of women taking oral contraceptives has fallen by more than two-thirds, from 420,600 in 2012/13 to 126,400 in 2022/23, according to the NHS data. Around 555,400 women turned to the health service's sexual and reproductive health services in 2022/23 — equivalent to four per cent of 13 to 54-year-olds Taken every day, it works by stopping the ovaries releasing an egg each month. It also thickens the cervical mucus and thinning the womb lining to stop sperm reaching an egg, and attaching itself in the womb. It is over 99 per cent effective with perfect use but if used incorrectly—such as missing a pill or experiencing nausea and diarrhoea while on it—around one in ten women (9 per cent) may get pregnant. Known side effects of the Pill include nausea, breast tenderness, mood swings and headaches. Others claim they pile on pounds while taking the because of increased fluid retention and appetite, yet the NHS says there is no evidence it leads to weight gain. Decades of research has failed to provide any conclusive evidence that this supposed side effect is real. However, rarer side effects include blood clots and a slightly heightened risk of breast and cervical cancer.
Yahoo
02-07-2025
- Health
- Yahoo
Certain type of hormone therapy increases breast cancer risk, study finds
Women using a certain type of hormone therapy to treat menopause symptoms could be at higher risk for breast cancer, according to a new study. The study, published Tuesday in The Lancet Oncology, found that estrogen plus progesterone increases the risk of breast cancer in women under 55 with a uterus, while estrogen alone reduces the risk. Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, told "CBS Mornings" Wednesday the study participants, all under age 55, were divided into two groups — women who still have their uterus and those who do not, since they require different types of treatment. A hysterectomy is the surgical removal of the uterus, which may be done for a number of reasons, including abnormal vaginal bleeding, severe pelvic pain, uterine fibroids, severe endometriosis and certain types of cancer. Approximately 600,000 females get hysterectomies in the U.S. each year, according to the Cleveland Clinic. "For the women who do still have a uterus, you have to give estrogen plus progesterone together. Estrogen alone will cause a thickening of the uterine lining, which can cause a different kind of cancer, what we call endometrial cancer. So you have to give the combination," Gounder said. "In women who no longer have a uterus, you can give estrogen alone." And the difference in treatment mattered. "What they found is estrogen alone reduced the risk of breast cancer," she said. "There seems to be a slight increase in risk in breast cancer if you also took progesterone." This research is a "great example of (how) science evolves," Gounder added. It comes after an early 2000s study called the Women's Health Initiative that focused on older women who may not have started hormone replacement therapy until 10 or so years after going through menopause. The study, which raised safety concerns and led to a longtime public misunderstanding around hormone therapy, has since been found problematic in terms of how it was designed. Now healthcare professionals largely consider the treatment option safe and effective. "The newer research is focused on what actually happens in real life, which is women who go through menopause in their 40s or 50s, (and) start treatment around that age," Gounder said. As with most medications, hormone replacement therapy comes with certain risks for some people. The Mayo Clinic notes it can lead to increased risk of heart disease, stroke, blood clots and some cancers. In other cases, however, it can help reduce risk of cancer, prevent bone loss and reduce menopausal symptoms like hot flashes. As the latest study shows, timing and type of hormone therapy can be crucial to potential outcomes, making it important that people consult their doctor and consider family history and other factors when considering treatment options. Gounder said hormone replacement therapy is the most effective treatment for a lot of perimenopausal symptoms, and added, "You really need to sit down and talk to your doctor (to determine) what is the appropriate thing for you." Extended interview: Iran's foreign minister Abbas Araghchi speaks to CBS News after U.S. strikes Details from inside the courtroom as Sean "Diddy" Combs jury announced verdict Split verdict in Sean "Diddy" Combs' sex trafficking and racketeering trial | Special Report
CBS News
02-07-2025
- Health
- CBS News
Certain type of hormone therapy increases breast cancer risk, study finds
Women using a certain type of hormone therapy to treat menopause symptoms could be at higher risk for breast cancer, according to a new study. The study, published Tuesday in The Lancet Oncology, found that estrogen plus progesterone increases the risk of breast cancer in women under 55 with a uterus, while estrogen alone reduces the risk. Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, told "CBS Mornings" Wednesday the study participants, all under age 55, were divided into two groups — women who still have their uterus and those who do not, since they require different types of treatment. A hysterectomy is the surgical removal of the uterus, which may be done for a number of reasons, including abnormal vaginal bleeding, severe pelvic pain, uterine fibroids, severe endometriosis and certain types of cancer. Approximately 600,000 females get hysterectomies in the U.S. each year, according to the Cleveland Clinic. "For the women who do still have a uterus, you have to give estrogen plus progesterone together. Estrogen alone will cause a thickening of the uterine lining, which can cause a different kind of cancer, what we call endometrial cancer. So you have to give the combination," Gounder said. "In women who no longer have a uterus, you can give estrogen alone." And the difference in treatment mattered. "What they found is estrogen alone reduced the risk of breast cancer," she said. "There seems to be a slight increase in risk in breast cancer if you also took progesterone." This research is a "great example of (how) science evolves," Gounder added. It comes after an early 2000s study called the Women's Health Initiative that focused on older women who may not have started hormone replacement therapy until 10 or so years after going through menopause. The study, which raised safety concerns and led to a longtime public misunderstanding around hormone therapy, has since been found problematic in terms of how it was designed. Now healthcare professionals largely consider the treatment option safe and effective. "The newer research is focused on what actually happens in real life, which is women who go through menopause in their 40s or 50s, (and) start treatment around that age," Gounder said. As with most medications, hormone replacement therapy comes with certain risks for some people. The Mayo Clinic notes it can lead to increased risk of heart disease, stroke, blood clots and some cancers. In other cases, however, it can help reduce risk of cancer, prevent bone loss and reduce menopausal symptoms like hot flashes. As the latest study shows, timing and type of hormone therapy can be crucial to potential outcomes, making it important that people consult their doctor and consider family history and other factors when considering treatment options. Gounder said hormone replacement therapy is the most effective treatment for a lot of perimenopausal symptoms, and added, "You really need to sit down and talk to your doctor (to determine) what is the appropriate thing for you."
The Independent
08-06-2025
- Health
- The Independent
Scientists celebrate bowel cancer breakthrough in bid to tackle surge in young people
Scientists have discovered that bowel cancer cells can transform into skin or muscle cells, allowing them to spread more aggressively. This breakthrough offers hope for treating the increasing rates of the disease, especially among young people. A study conducted by the Cancer Research UK Scotland Centre and the University of Edinburgh revealed that a critical step in aggressive bowel cancer involves cells losing their original identity, a process known as cellular plasticity. Researchers found that the disease spreads when colonic cells begin to resemble squamous cells, which form skin, or muscle cells. Bowel cancer is the second most common cause of cancer deaths in the UK. It claims the lives of 16,800 people in Britain, including 1,700 in Scotland, every year and is increasingly being diagnosed in younger people internationally. A recent study by the American Cancer Society published in The Lancet Oncology showed early-onset bowel cancer rates in adults aged 25-49 are rising in 27 of 50 countries studied, and increasing faster in young women in Scotland and England than in young men. Scotland is disproportionately affected with around 4,000 people diagnosed each year overall, according to Cancer Research UK. The latest study found bowel cancer cells can adapt to resemble skin cells, which can tolerate much harsher day-to-day conditions due to their role and position protecting the outside of the body, and also muscle cells, both of which are more 'robust'. Cellular plasticity was found to be an important element in bowel cancer metastasis – when it spreads and becomes harder to treat. Researchers hope identifying this and preventing it could help make current treatments more effective and stop the disease from spreading. The study also examined a particular gene called Atrx which was already associated with aggressive forms of bowel cancer. Using mice and human tissue samples, researchers found the loss of this gene resulted in increased metastatic tumours which spread from the bowel to the liver, lymph nodes and the diaphragm. Key to the ability of these cells to spread is that they shed their identity of colonic cells and resembled squamous cells which form skin, or cells that resemble muscle. The paper, 'Loss Of Colonic Fidelity Enables Multilineage Plasticity And Metastasis', is published in Nature. The research received funding from the Medical Research Council and the European Research Council. Dr Kevin Myant, of the Institute of Genetics and Cancer at the University of Edinburgh and the Cancer Research UK Scotland Centre, said: 'With more and more younger people being diagnosed with bowel cancer, it's vital we understand how this disease grows and develops. 'Our research has discovered one way that aggressive bowel cancer is able to spread is by 'shapeshifting' to resemble skin or muscle cells rather than bowel cancer cells. 'This finding will hopefully allow us to develop new treatments to stop these cells changing and prevent the cancer spreading, when it becomes much harder to treat.' Lead researcher Dr Patrizia Cammareri said: 'Skin cells can tolerate much harsher day-to-day conditions than other types of cells – due to their role and position protecting the outside of the body – so this may be a strategy to help the bowel cancer cells become more robust and enable them to spread around the body. 'Metastasis is a leading cause of cancer death and a key focus for cancer research, so this finding could be pivotal in halting the progression of aggressive cancer and providing better outcomes for patients.' Cancer Research UK director of research, Dr Catherine Elliott, said: 'Diagnosing and treating cancer early and preventing spread to other parts of the body offers the best chance of a positive outcome for patients so research like this, which could lead to new ways to stop that spread, offers great hope. 'Bowel cancer is of increasing concern globally, which is why we invested £5.5m to the CRC-STARS initiative (Colorectal Cancer – Stratification of Therapies through Adaptive Responses) jointly led by our Cancer Research UK Scotland Institute, which will bring together more than 40 bowel cancer experts, including researchers who worked on this project, to find new and kinder ways to tackle this disease.'
Yahoo
02-06-2025
- Business
- Yahoo
Jazz Pharmaceuticals Reports Clinically Meaningful Long-Term Median Overall Survival Data for Ziihera® (zanidatamab-hrii) in First-Line HER2-Positive Metastatic Gastroesophageal Adenocarcinoma at ASCO 2025
Phase 2 trial results continue to show clinically meaningful efficacy and durable responses, including 36.5-month median overall survival after four years of follow-up, with a manageable safety profile Findings presented today at ASCO 2025 and concurrently published in The Lancet Oncology For U.S. media and investors only DUBLIN, June 2, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced long-term data, including the first report of median overall survival (OS) from the Phase 2 trial evaluating Ziihera® (zanidatamab-hrii), a dual HER2-targeted bispecific antibody, in combination with chemotherapy for the investigational use in first-line HER2-positive (IHC 3+ or IHC 2+/FISH+) locally advanced nonresectable gastroesophageal adenocarcinoma (mGEA). The data were featured as a rapid oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, and the results were concurrently published in The Lancet Oncology. Among 41 patients with centrally confirmed HER2-positive tumors, treatment with Ziihera in combination with physician's choice of chemotherapy resulted in a median progression-free survival (PFS) of 15.2 months [95% CI: 9.5, 33.4], and a median overall survival (OS) of 36.5 months [95% CI: 23.6, not estimable (NE)]. Median PFS remained stable with the additional four-year follow-up, consistent with previously reported results. Among all 46 patients in the study with HER2-expressing mGEA, median PFS was 12.5 months [95% CI: 8.2, 21.8], and median OS also reached 36.5 months [95% CI: 23.6, NE], with the longest observed survival at 57.9 months (censored at data cutoff). Long-term follow-up also demonstrated low discontinuation rates, with no new safety signals observed. "Gastroesophageal adenocarcinoma remains a highly aggressive cancer with a poor prognosis, even with currently available treatment options," said Dr. Elena Elimova, lead trial investigator and a medical oncologist at Princess Margaret Cancer Centre, Toronto, Canada. "The long-term survival outcomes presented today at ASCO demonstrate the sustained antitumor activity achieved with zanidatamab plus chemotherapy over four years of follow-up. These results are especially encouraging given the high unmet need for better first-line treatment options for this patient population." "These long-term survival data from our Phase 2 trial build on previously reported results and further strengthen our belief in Ziihera as a transformative treatment option for patients with HER2-positive disease," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "An estimated median overall survival of 36.5 months in this patient cohort is very encouraging given recent observations with standard of care regimens in similar populations, where median survival has typically ranged from 15 to 20 months. The sustained 15.2-month progression-free survival in the centrally confirmed HER2-positive subgroup after four years is a meaningful indicator of durable clinical benefit. We look forward to the top line results of the pivotal Phase 3 HERIZON-GEA-01 trial later this year and remain committed to advancing Ziihera across multiple tumor types." Phase 2 mGEA Trial Results The data include four-year follow-up and the first report of median OS from an ongoing, open-label Phase 2 trial (NCT03929666) evaluating Ziihera in combination with chemotherapy as a first-line treatment for patients with HER2-expressing mGEA, which includes gastric, esophageal and gastroesophageal junction (GEJ) adenocarcinomas. Patients had not received prior HER2-targeted agents nor systemic treatment for mGEA. A total of 46 patients with HER2-expressing mGEA (41 patients with centrally confirmed HER2-positive mGEA) were enrolled from 14 sites across the United States, Canada and South Korea. Patients received Ziihera with physician's choice of chemotherapy, including fluoropyrimidine maintenance regimens. Chemotherapy-based regimens remain the current standard first-line treatment for mGEA. The longer-term data (median duration of follow-up of 48 months [range, 29-59]) demonstrate the promising antitumor activity of Ziihera combined with chemotherapy as a first-line treatment for HER2-positive mGEA. In a post-hoc subgroup analysis of the 41 treated patients with centrally confirmed HER2-positive tumors, median PFS was 15.2 months [95% CI: 9.5, 33.4], and median OS was 36.5 months [95% CI: 23.6, NE]. These survival outcomes were consistent with prior analyses, with PFS durability maintained at the four-year follow-up. The confirmed objective response rate (cORR), the study's primary endpoint, was 83.8% [95% CI: 68.0, 93.8], and median duration of response (DOR) was 20.4 months [95% CI: 8.3, 44.1]. These results further support the observed clinical benefit in this centrally confirmed population. Among all 46 patients in the study, median PFS was 12.5 months [95% CI: 8.2, 21.8], and the estimated 24-month PFS rate was 31% [95% CI: 17%, 46%]. Median OS was also 36.5 months [95% CI: 23.6, NE], with an estimated 24-month OS rate of 65% [95% CI: 49%, 77%]. The cORR was 76.2% [95% CI: 60.5, 87.9], and median DOR was 18.7 months [95% CI: 10.4, 44.1]. With additional follow-up, the safety and tolerability profile of Ziihera plus chemotherapy showed low discontinuation rates, with no new safety signals identified. Diarrhea (39%) and hypokalemia (22%) were the most common Grade 3-4 treatment-related adverse events (TRAEs); the incidence of Grade 3 diarrhea was reduced from 52% to 24% for patients enrolled after the implementation of mandated antidiarrheal prophylaxis. There were no treatment-related deaths. Five patients discontinued Ziihera due to TRAEs. Ongoing Phase 3 TrialThe Phase 3 randomized clinical trial, HERIZON-GEA-01 (NCT05152147), evaluating Ziihera in combination with standard of care chemotherapy with and without the addition of a PD-1 agent as a first-line treatment for HER2-expressing mGEA is currently underway. This is an events-based trial, and top-line results are expected to read out in the second half of 2025. About Gastroesophageal AdenocarcinomaGastroesophageal adenocarcinoma (GEA) is the fifth most common cancer worldwide, and approximately 20% of patients have HER2-positive disease.i,ii,iii HER2-positive GEA has high morbidity and mortality, and patients are urgently in need of new treatment options. The overall prognosis for patients with GEA remains poor, with a global five-year survival rate of less than 30 percent for gastric cancer and about 19 percent for About Ziihera® (zanidatamab-hrii) Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.v In the United States, Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.v The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). v Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule. The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. Important Safety Information for ZIIHERA WARNING: EMBRYO-FETAL TOXICITYExposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patientsof the risk and need for effective contraception. WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity ZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA. Left Ventricular Dysfunction ZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7). LVD resolved in 70% of patients. Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions. The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%. Infusion-Related Reactions ZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day. Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use. If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs. Diarrhea ZIIHERA can cause severe diarrhea. Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity. ADVERSE REACTIONS Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%). A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA. The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%). USE IN SPECIFIC POPULATIONS Pediatric Use Safety and efficacy of ZIIHERA have not been established in pediatric patients. Geriatric Use Of the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older. No overall differences in safety or efficacy were observed between these patients and younger adult patients. The full U.S. Prescribing Information for ZIIHERA, including BOXED Warning, is available at: About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Jazz Pharmaceuticals plc Caution Concerning Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements related to zanidatamab's potential as a transformative treatment option for patients with HER2-positive disease, expected timing of top-line results of the pivotal Phase 3 HERIZON-GEA-01 and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the successful completion of regulatory activities and uncertain regulatory approval, risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients and other risks and uncertainties affecting Jazz Pharmaceuticals and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2024, as supplement by Jazz Pharmaceuticals' Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. Contacts: Media Contact:Kristin BhavnaniHead of Global Corporate CommunicationsJazz Pharmaceuticals plcCorporateAffairsMediaInfo@ +353 1 637 2141U.S. +1 215 867 4948 Investors: Jeff Macdonald Executive Director, Investor RelationsJazz Pharmaceuticals plcinvestorinfo@ Ireland +353 1 634 3211 U.S. +1 650 496 2717 i Abrahao-Machado I.F., et al. HER2 testing in gastric cancer: An update WorldJGastroenterol. 2016;22(19):4619-4625. ii Van Custem E., et al. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer. 2015;18(3):476-484. iii Stroes, C.I., et al. A systematic review of HER2 blockade for the curative treatment of gastroesophageal adenocarcinoma: Successes achieved and opportunities ahead. CancerTreatRev. 2021;99:102249. iv Battaglin F, et al. Molecular biomarkers in gastro-esophageal cancer: recent developments, current trends and future directions. Cancer Cell International. 2018;18(99). v ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.). View original content to download multimedia: SOURCE Jazz Pharmaceuticals plc
