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Pfizer & Astellas Pharma’s XTANDI Gains Supplemental FDA-Approval For The Treatment Of Metastatic Castration-Sensitive Prostate Cancer

By John F. Heerdink, Jr.

Pfizer (PFE)  is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products. Recently, Pfizer announced the results of the interim analysis of the Phase 3 BEACON CRC trial with a combination of BRAFTOVI® (encorafenib), MEKTOVI® (binimetinib), and cetuximab (BRAFTOVI Triplet) with patients suffering from advanced BRAFV600E-mutant metastatic colorectal cancer.

As per reports, a supplemental New Drug Application for XTANDI has been approved by the U.S. Food and Drug Administration used for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). In 2019, it is estimated that +40,000 men in the United States are living with mCSPC. Prostate cancer is treated metastatic once it spreads outside of the prostate gland to other parts of the body like the bones, lymph nodes, bladder, and rectum. The announcement came from Pfizer and Astellas Pharma Inc, President and CEO, Kenji Yaskawa making XTANDI the first and only oral treatment FDA approved in three distinct types of advanced prostate cancer including non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC. Reportedly, it is estimated that just over 40,000 men in the United States are living with mCSPC

Andrew Armstrong, M.D., Professor of Medicine, Surgery, Pharmacology and Cancer Biology, Director of Research in the Duke Cancer Institute’s Center for Prostate and Urologic Cancers and lead investigator of ARCHES stated, “Men with metastatic castration-sensitive prostate cancer face complex treatment decisions and it is critical for physicians and patients to have as much information as possible when deciding on all of the options available,”, “The research supporting the FDA approval and updated treatment guidelines provide physicians and patients with compelling evidence to consider enzalutamide as a treatment option for men with this disease.”

“Today’s approval adds to over a decade of global clinical research aimed at better understanding the potential benefit of XTANDI for men with advanced prostate cancer,” “The FDA approval marks continued progress to help meet the needs of patients, including men living with metastatic castration-sensitive prostate cancer,” stated Andy Schmeltz, Global President, Pfizer Oncology.

Pfizer and Astellas have been working to help patients connect with XTANDI by providing them with access and reimbursement support resources. Patients can visit or connect with XTANDI Support Solutions at 1-855-898-2634 for more assistance.

To learn more about Pfizer (PFE) and to track its progress please visit the Vista Partners Pfizer Coverage Page.

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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(Read Original Story: XTANDI® (enzalutamide) Approved by U.S. FDA for the Treatment of Metastatic Castration-Sensitive Prostate Cancer in Business Wire)


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