For Media: shin.ohkubo@astellas.com. Contract Research Organisation for Clinical Trials, 12th February 2020 (Last Updated February 12th, 2020 10:41). About Pfizer OncologyAt Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients. PROSPER enrolled patients with prostate cancer that had progressed, based on a rising PSA level despite ADT, but who had no symptoms and no prior or present evidence of metastatic disease. ; The partnered companies had announced the success of the Phase 3 ARCHES study last December. Creating Cures Through Facility Investments, Scaling Up to Supply a COVID-19 Vaccine, If Approved. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. For help with XTANDI, please call 1-855-898-2634. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. Dec 16 (Reuters) - The U.S. Food and Drug Administration has approved Pfizer Inc and Astellas Pharma Inc’s Xtandi to treat patients with a type of prostate cancer, the companies said on Monday. Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. Discontinuations with an AE as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients. In the combined data of four randomized, placebo-controlled clinical studies, falls occurred in 11% of patients treated with XTANDI compared to 4% of patients treated with placebo. XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer. XTANDI (enzalutamide) is an androgen receptor inhibitor jointly developed by Astellas Pharma and Pfizer. Since its initial approval in 2012, XTANDI has been prescribed to more than 330,000 men worldwide. Key secondary endpoints included overall survival, time to PSA progression and time to first use of antineoplastic therapy. Treatment of nonmetastatic castration-resistant prostate cancer. Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice. Falls and Fractures occurred in patients receiving XTANDI. Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., 'Astellas') and Pfizer Inc. (NYSE: PFE) announced today results of the final overall survival (OS) analysis from the Phase 3 PROSPER trial, which evaluated XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC). Shin Okubo Pfizer and Astellas are committed to helping patients access XTANDI by providing them with access and reimbursement support resources, including information regarding patient healthcare coverage options and financial assistance options that may … XTANDI (enzalutamide) sponsored by Astellas Pharma Inc. and Pfizer Inc. Add to Favorites . About Non-Metastatic Castration-Resistant Prostate Cancer, Castration-resistant prostate cancer (CRPC) refers to the subset of men whose prostate cancer progresses on androgen deprivation therapy (ADT) despite castrate levels of testosterone (i.e., less than 50 ng/dL).2 Non-metastatic CRPC means there is no clinically detectable evidence of the cancer spreading to other parts of the body (metastases), and there is a rising prostate-specific antigen (PSA) level.3 Many men with non-metastatic CRPC and a rapidly rising PSA level go on to develop metastatic CRPC.4. As part of Pfizer and Astellas’ ongoing commitment to the clinical development of enzalutamide, XTANDI is also being evaluated in the EMBARK trial, in men with high-risk non-metastatic HSPC. Call XTANDI Support Solutions ® at 1-855-8XTANDI (1-855-898-2634). The companies said the median time for the primary endpoint of metastasis-free survival (MFS), was 36.6 months for men who received Xtandi in comparison to 14.7 months for those who only had the ADT … About the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. 847-224-3014 New England Journal of Medicine. Permanently discontinue XTANDI for serious hypersensitivity reactions. Pfizer and Astellas’ Xtandi is already approved to treat nonmetastatic castration-resistant prostate cancer, thanks to data showing it can stop tumors from spreading. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. The trial evaluated enzalutamide at a dose of 160 mg taken orally once daily plus ADT, versus placebo plus ADT. See data on XTANDI® & how it may treat 3 forms of prostate cancer, non-metastatic castration-resistant prostate cancer, metastatic CRPC, & metastatic castration-sensitive prostate cancer. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. Full Prescribing Information; Patient Information; XTANDI is a prescription medicine used to treat men with prostate cancer that: no longer responds to a hormone therapy or surgical treatment to lower testosterone; OR. Discontinue XTANDI for Grade 3-4 ischemic heart disease. Ryan Crowe For more information on the PROSPER trial, go to www.clinicaltrials.gov. Pharyngeal edema has been reported in post-marketing cases. Discontinue XTANDI in patients who develop PRES. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. About the Pfizer/Astellas Collaboration. We can also answer questions about insurance coverage and your out-of-pocket costs. About XTANDI® (enzalutamide)XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. chris.goldrick@astellas.com, For Investors: Pfizer and its development partner Astellas Pharma released data late Monday showing the treatment efficacy in patients with non-metastatic Castration-Resistant Prostate Cancer (CRPC). Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. Please see Full Prescribing Information for additional safety information. Important Safety Information. In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. XTANDI. Discontinuations due to adverse events (AEs) were reported for 16% of XTANDI-treated patients. Chris Goldrick A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. In PROSPER, the placebo-controlled study of non-metastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. OCT West Coast: how can decentralisation help optimise rare disease trials? Fractures occurred in 10% of patients treated with XTANDI and in 4% of patients treated with placebo. TOKYO & Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. 212-733-6213 In the data from the four randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were asthenia/fatigue, back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, and hypertension. 4 Smith MR, Kabbinavar F, Saad F, et al. Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Xtandi is an androgen receptor inhibitor approved to treat castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Jessica Smith 1 Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI ® (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher AEs were reported in 24% of XTANDI-treated patients. 1 Hussain M, Fizazi K, Saad F, et al. Contact Contact. There is troubling news for Pfizer and cancer med Xtandi, a shared asset it picked up in its $14 billion deal last year for Medivation. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. This release contains forward-looking information about XTANDI® (enzalutamide), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Hypertension: In the combined data from four randomized placebo-controlled clinical trials, hypertension was reported in 12% of XTANDI patients and 5% of placebo patients. In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. 3 Luo J, Beer T, Graff J. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States. XTANDI is currently indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC). If co-administration is necessary, increase the dose of XTANDI. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. The information contained in this release is as of February 11, 2020. About the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI. XTANDI, Astellas, and the flying star logo are registered trademarks of Astellas Pharma Inc. XTANDI Support Solutions®, a component of Astellas Pharma Support SolutionsSM, is a registered trademark of Astellas Pharma US, Inc.© 2021 Astellas Pharma US, Inc. and Pfizer Inc. If you continue to use this site we will assume that you are happy with it. Pfizer and Astellas report positive results of Xtandi in cancer 12th February 2020 (Last Updated February 12th, 2020 10:41) Pfizer and Astellas Pharma have reported positive results from the Phase III PROSPER clinical trial of Xtandi (enzalutamide) in patients with non … Discontinuations with an AE as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients. The primary endpoint of the PROSPER trial, metastasis-free survival (MFS), was measured as the time from patients entering the trial until their cancer was radiographically detected as having metastasized, or until death, within 112 days of treatment discontinuation. OS was a key secondary endpoint of the trial. Getting to Know CPO Dara Richardson-Heron, M.D. OCT West Coast: IQVIA’s Nagaraja Srivatsan talks decentralised trials and the future of clinical research. Today, Pfizer Oncology has an industry-leading portfolio of 22 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, prostate, kidney and lung cancers, as well as leukemia and melanoma. Characterising the castration-resistant prostate cancer population: a systematic review. Pfizer will add its much-vaunted marketing talents to Astellas' efforts, in a bid to make sure that happens. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Evaluate patients for fracture and fall risk. Monitor for signs and symptoms of ischemic heart disease. In a preliminary analysis, adverse events were generally consistent with those previously reported from PROSPER. Patients whose prostate cancer had progressed without any symptoms and no previous or current evidence of metastatic disease participated in the trial. J Clin Oncol 2005;23(13):2918-25. If co-administration is necessary, reduce the dose of XTANDI. 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About the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. On Monday, the U.S. Food and Drug Administration (FDA) greenlit the new indications for Xtandi (enzalutamide). The modifications revised the planned analyses of the primary and secondary endpoints of the trials, as well as their scheduled primary completion date. Find contact information for Astellas Pharma US, Inc. and Pfizer Inc. for XTANDI® (enzalutamide). Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments. Hypertension led to study discontinuation in < 1% of patients in each arm. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States. TOKYO and NEW YORK, February 11, 2020 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) announced today results of the final overall survival (OS) analysis from the Phase 3 PROSPER trial, which evaluated XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC). The primary endpoint was metastasis-free survival (MFS), defined as the time from patients enrolling in the trial until their cancer was found to have metastasised, or until death within 112 days after treatment discontinuation. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September 2016. The forward-looking statements in the webcast speak only as of the original date of the webcast. Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in seven randomized clinical trials. For Media: These results were presented at the Genitourinary Cancers Symposium (ASCO GU) and later published in the New England Journal of Medicine.1. For help with XOSPATA, please call 1-844-632-9272. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer. Permanent discontinuation due to AEs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients. Grade 3-4 ischemic events occurred in 1.4% of patients on XTANDI versus 0.7% on placebo. About the Pfizer/Astellas CollaborationIn October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. Editor's note: This story was updated to include Astellas' role as Pfizer's Xtandi partner. About AstellasAstellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer. Astellas Forward-Looking StatementIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. Pfizer. The results demonstrated a statistically significant improvement in OS in patients with nmCRPC who were treated with XTANDI plus ADT. For more information, please visit our website at https://www.astellas.com/en. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring. Discontinuations due to AEs were reported for 6% of XTANDI-treated patients. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer. We use cookies to ensure that we give you the best experience on our website. Ischemic Heart Disease In the combined data of four randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (2.9% vs 1.3%). Pfizer Oncology is striving to change the trajectory of cancer. Warnings and Precautions. Preliminary analysis showed an adverse event profile generally consistent with previous PROSPER data. Pfizer Contacts: The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. Final analysis of OS data revealed a statistically significant improvement in the OS of patients treated with Xtandi plus ADT compared to the placebo and ADT combination. A description of these risks and uncertainties can be found in Pfizer’s most recent Annual Report on Form 10-K and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss. The randomised, double-blind, placebo-controlled, multi-national PROSPER study assessed a 160mg dose of the drug in combination with androgen deprivation therapy (ADT) in a total of around 1,400 nmCRPC patients in the US, Europe, Canada, South America and Asia-Pacific. The Phase 3 randomized, double-blind, placebo-controlled, multi-national trial enrolled approximately 1,400 patients with nmCRPC at sites in the United States, Canada, Europe, South America and the Asia-Pacific region. This webcast may contain forward-looking statements about, among other things, our anticipated future operating and financial performance, business plans and prospects, in-line products and product candidates, strategic reviews, capital allocation, business-development plans, the benefits expected from the reorganization of our commercial operations into three businesses effective at the beginning of our 2019 fiscal year, our acquisitions and other business development activities, our proposed transaction with GSK to combine our respective consumer healthcare businesses into a new consumer healthcare joint venture, our ability to successfully capitalize on growth opportunities or prospects, manufacturing and product supply and plans relating to share repurchases and dividends, among other things, that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Permanently discontinue XTANDI in patients who develop a seizure during treatment. About the Pfizer/Astellas Collaboration. Learn how the Astellas Patient Assistance Program can offer XTANDI® to eligible patients at no cost. As part of Pfizer and Astellas’ ongoing commitment to the clinical development of enzalutamide, XTANDI is also being evaluated in the EMBARK trial, in men with high-risk non-metastatic HSPC. Ryan.Crowe@pfizer.com, Astellas Contacts: See risks & benefits. Xtandi, the prostate cancer drug developed by Pfizer and Japan-based Astellas, won approval for a new indication as a treatment for patients with metastatic castration-sensitive prostate cancer (mCSPC). GlobalData's TMT Themes 2021 Report tells you everything you need to know about disruptive tech themes and which companies are best placed to help you digitally transform your business. Data on File. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. PROSPER efficacy and safety data at the time of the MFS analysis are included in the XTANDI labels in the U.S., Europe and Japan and are currently under review in China. to speak with a dedicated access specialist who can help you find ways to pay for XTANDI. 2 Kirby M, Hirst C, Crawford ED. In 2018, Astellas and Pfizer announced that the PROSPER trial met its primary endpoint of metastasis-free survival (MFS).
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