2 Kirby M, Hirst C, Crawford ED. About the Pfizer/Astellas Collaboration. 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. The submission is based on results from the Phase 3 ARCHES trial presented at the 2019 Genitourinary Cancers Symposium (ASCO GU) in February and published in The Journal of Clinical Oncology in July 2019. Discontinuations with an AE as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients. Oncology 2016;30(4):336-44. If you continue to use this site we will assume that you are happy with it. Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. Contract Research Organisation for Clinical Trials, 12th February 2020 (Last Updated February 12th, 2020 10:41). Find contact information for Astellas Pharma US, Inc. and Pfizer Inc. for XTANDI® (enzalutamide). A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of XTANDI; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications for XTANDI may be filed in any other jurisdictions; whether and when regulatory authorities in any jurisdictions where applications may be pending or filed may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether XTANDI will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of XTANDI; risks related to increasing competitive, reimbursement and economic challenges; dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; and competitive developments. Jessica Smith
Grade 3-4 ischemic events occurred in 1.4% of patients on XTANDI versus 0.7% on placebo. Pfizer Oncology is striving to change the trajectory of cancer. J Clin Oncol 2005;23(13):2918-25. Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer. Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. 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. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. 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. Dive Brief: Pfizer and Astellas Pharma released data Monday showing a combination of Xtandi and androgen deprivation therapy (ADT) significantly reduced the risk of death or radiographic progression by 61% compared to ADT alone in a certain type of prostate cancer. Evaluate patients for fracture and fall risk. XTANDI, Astellas, and the flying star logo are registered trademarks of Astellas Pharma Inc. XTANDI Support Solutions®, a component of Astellas Pharma Support Solutions SM, is a registered trademark of Astellas Pharma US, Inc. QUICK START+® is a registered trademark of Astellas Pharma US, Inc. 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. OCT West Coast: how can decentralisation help optimise rare disease trials? Discontinuations with an AE as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients. 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. 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. 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. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. The information contained in this release is as of February 11, 2020. We can also answer questions about insurance coverage and your out-of-pocket costs. The trial evaluated enzalutamide at a dose of 160 mg taken orally once daily plus ADT, versus placebo plus ADT. CytoDyn doses subjects in long-haulers Covid-19 therapeutic trial, Kintor’s Proxalutamide lowers mortality in Covid-19 patients, THREAD and CureClick announce partnership for trial recruitment, Q&A with N-SIDE’s Sébastien Coppe: how digitisation overcomes clinical bottlenecks, Cuba’s homegrown Covid-19 vaccines advance into late-stage trials, OCT West Coast: the post-pandemic outlook for clinical trials, AstraZeneca/Fibrogen’s Roxadustat FDA Review Further Delayed Following Unanticipated Advisory Committee Request, Altasciences completes acquisition of US-based CRO WCCT Global, Investment firm GI Partners closes Clinical Ink acquisition, Investment firm GI Partners to acquire minority interest in Clinical Ink, Rigel concludes subject enrolment in NIH-sponsored Covid-19 trial, the partners amended the protocols of the ARCHES and EMBARK registrational Phase III trials, Globalisation of US cancer trials is reducing enrolment of Black patients, study finds, Roche’s Evrysdi is a strong contender for SMA market share following EMA nod. Shin Okubo
Pfizer will add its much-vaunted marketing talents to Astellas' efforts, in a bid to make sure that happens. OS was a key secondary endpoint of the trial. Pfizer and Astellas’ Xtandi is already approved to treat nonmetastatic castration-resistant prostate cancer, thanks to data showing it can stop tumors from spreading. Jessica.M.Smith@pfizer.com, For Investors:
For Media:
Important Safety Information. 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. Call Us. XTANDI (enzalutamide) is an androgen receptor inhibitor jointly developed by Astellas Pharma and Pfizer. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. 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. XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer. Pfizer. Detailed efficacy and safety results from the final PROSPER OS analysis will be shared at a later date. 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. 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. 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. The trial met its primary endpoint of MFS in 2018. 212-733-6213
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. Northbrook, IL: Astellas Pharma US, Inc. 2. 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 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. 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 Pfizer and Astellas Pharma have reported positive results from the Phase III PROSPER clinical trial of Xtandi (enzalutamide) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). ; The partnered companies had announced the success of the Phase 3 ARCHES study last December. See risks & benefits. Warnings and Precautions. Key secondary endpoints included overall survival, time to PSA progression and time to first use of antineoplastic therapy. Discontinue XTANDI for Grade 3-4 ischemic heart disease. Monitor for signs and symptoms of ischemic heart disease. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Contact Contact. 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. 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. 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. 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. 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. The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. 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. 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. This information is intended for US Healthcare professionals. 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. Discontinue XTANDI in patients who develop PRES. to speak with a dedicated access specialist who can help you find ways to pay for XTANDI. Treatment of nonmetastatic castration-resistant prostate cancer. The results demonstrated a statistically significant improvement in OS in patients with nmCRPC who were treated with XTANDI plus ADT. 212-733-8160
In a preliminary analysis, adverse events were generally consistent with those previously reported from PROSPER. Please see Full Prescribing Information for additional safety information. 3 Luo J, Beer T, Graff J. 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. Ryan Crowe
For help with XOSPATA, please call 1-844-632-9272. 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). Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. Patients whose prostate cancer had progressed without any symptoms and no previous or current evidence of metastatic disease participated in the trial. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Editor's note: This story was updated to include Astellas' role as Pfizer's Xtandi partner. 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). For more information on the PROSPER trial, go to www.clinicaltrials.gov. 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. Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, and hypercalcemia. Chris Goldrick
It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. XTANDI (enzalutamide) sponsored by Astellas Pharma Inc. and Pfizer Inc. Add to Favorites . 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. The modifications revised the planned analyses of the primary and secondary endpoints of the trials, as well as their scheduled primary completion date. 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). Pharyngeal edema has been reported in post-marketing cases. 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. 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). 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. 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 … 81-3-3244-3202
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. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek” and other words and terms of similar meaning. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring. Factors that could cause actual results to differ materially from past results and future plans and projected future results are described in our Form 8-K furnished with the U.S. Securities and Exchange Commission on January 12, 2021 and linked here, which also contains information regarding our use of preliminary financial guidance. 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. Xtandi is an androgen receptor inhibitor approved to treat castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Preliminary analysis showed an adverse event profile generally consistent with previous PROSPER data. 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. XTANDI is currently indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC). 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. 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. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. Since its initial approval in 2012, XTANDI has been prescribed to more than 330,000 men worldwide. 1 Hussain M, Fizazi K, Saad F, et al. XTANDI. Falls and Fractures occurred in patients receiving XTANDI. Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. 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. Learn how the Astellas Patient Assistance Program can offer XTANDI® to eligible patients at no cost. Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September 2016. Discontinuations due to adverse events (AEs) were reported for 16% of XTANDI-treated patients. Fractures occurred in 10% of patients treated with XTANDI and in 4% of patients treated with placebo. Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. In 2018, Astellas and Pfizer announced that the PROSPER trial met its primary endpoint of metastasis-free survival (MFS). XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Pfizer Contacts:
Ryan.Crowe@pfizer.com, Astellas Contacts:
847-224-3014
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. In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. On Monday, the U.S. Food and Drug Administration (FDA) greenlit the new indications for Xtandi (enzalutamide). OCT West Coast: IQVIA’s Nagaraja Srivatsan talks decentralised trials and the future of clinical research. 4 Smith MR, Kabbinavar F, Saad F, et al. In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher AEs were reported in 24% of XTANDI-treated patients. chris.goldrick@astellas.com, For Investors:
Key secondary endpoints of the trial included overall survival (OS), time to prostate-specific antigen (PSA) progression, and time to first antineoplastic therapy use. 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. 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. Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments. 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%). 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). Call XTANDI Support Solutions ® at 1-855-8XTANDI (1-855-898-2634). 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.