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

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.

Suggested Articles

Mylan recalls one lot of the injectable antibiotic daptomycin after discovering particles in a single-dose vial.

AbbVie's Allergan received a positive early ruling in its long-running trade secrets dispute with Evolus over a competitor to blockbuster Botox.

As Amgen ramps up clinical trials of its psoriasis drug Otezla in COVID-19, it might also be studying its blockbuster Enbrel in fighting the virus.