FDA Approves XTANDI (enzalutamide, formerly MDV-3100) for ROYAL Shade Prostate Cancer Patients

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The Prostate Cancer Research Institute is pleased with the recent announcement of the FDA's approval of a new medication for men with advanced prostate cancer.

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The entire story behind this drug is an example of the pharmaceutical companies, FDA, and prostate cancer community working together.

Pharmaceutical companies Medivation, Inc. and Astellas Pharma Inc. announced Friday that the FDA has approved the drug XTANDI (enzalutamide, previously known as MDV-3100) for men with metastatic, castration-resistant prostate cancer who have previously been treated with docetaxel (chemotherapy).

The Prostate Cancer Research Institute is excited about the availability of this new therapy, which was approved sooner than expected. The drug was initially expected to be FDA-approved November 22.

“The entire story behind this drug is an example of the pharmaceutical companies, FDA, and prostate cancer community working together,” said Jan Manarite, senior educational facilitator for PCRI. Manarite also serves on the Early/Expanded Access Program committee, which negotiates access to phase 3 medications for people with advanced cancer during the 6-12 month window while FDA approval is pending.

“We are very happy to see the FDA approve this important, new medication,” said PCRI executive director Mark Scholz, MD. “The PCRI encourages men with advanced prostate cancer to contact their doctors to determine if they are eligible to receive this active and well-tolerated form of anticancer therapy.”

XTANDI (generic name enzalutamide) is an androgen receptor inhibitor that is taken orally in capsule form once a day. Studies indicate notable anti-cancer activity with relatively modest side effects.

"This is yet another major milestone in the fight against a disease that we are beginning to win,” said Mark Moyad, MD, who co-chairs the Expanded Access committee. “If we can continue to support this research momentum, it is possible that soon this drug and others will also help many men with less advanced prostate cancers, and other individuals with other forms of cancer."

About PCRI

The Prostate Cancer Research Institute is a charitable non-profit organization dedicated to supporting research to improve the quality of men’s lives, and providing information that both educates and empowers patients, families and the medical community. Founded in 1996 by internationally recognized prostate cancer oncologists Mark C. Scholz, MD and Stephen B. Strum, MD, with support from Daniel Freeman Hospital Foundation, PCRI provides programs and services to support their mission and goals. Such programs and resources include a help line, an informative and up-to-date website, newsletters, annual conferences, advocacy, and research.

For more information, visit http://www.prostate-cancer.org.

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