Pfizer, Astellas' Xtandi matches J&J's rival Erleada with new prostate cancer nod

The new indication for Xtandi affects around 40,000 men in the U.S. each year, Pfizer said. (Pfizer)

Pfizer and Astellas' stalwart prostate cancer med Xtandi has watched as Johnson & Johnson's challenger, Erleada, picked up the lead in the metastatic, castration-sensitive form of the disease. But now, Xtandi is ready to take on its familiar foe with a new green light of its own.

The FDA on Monday approved Xtandi as a treatment for metastatic, castration-sensitive prostate cancer (mCSPC), making it the only drug approved in that indication as well as in metastatic and non-metastatic, castration-resistant prostate cancer. 

RELATED: Pfizer, Astellas rocket toward broader Xtandi use with FDA 'priority' tag


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The new approval will open Xtandi up for use in a patient population that includes about 40,000 U.S. males each year, Pfizer said in a release. And to get it out to them, the Pfizer-Astellas team will lean on its extensive network of oncologists. That marketing effort has translated to 420,000 patients treated since the drug was initially approved in 2012, Pfizer said.

"There is significant physician and comfort with Xtandi so we hope that this approval will build upon that," Chris Boshoff, Pfizer Oncology's chief development officer, said ahead of the approval.