J&J wins snap approval of apalutamide, the first drug OK’d for nonmetastatic prostate cancer

Richard Padzur

The FDA has given J&J a big boost today, cutting its priority review for apalutamide down to a quick once over and a snap approval months ahead of its PDUFA date for nonmetastatic prostate cancer.

The drug will now be sold as Erleade, handily beating a rival supplemental application from Pfizer on its cancer drug Xtandi. This approval came through just two months after the agency offered to give it a priority review, underscoring how fast regulators are willing to act.

Evaluate Pharma has pegged 2022 sales at $1.6 billion for apalutamide, flagging some of the zeal that analysts have for this drug. A spokesperson for the company says that the “wholesale acquisition cost (WAC) of a 30-day supply of ERLEADA is $10,920.00 per bottle of 120 tablets (60 mg tablets), which is in line with other oral oncology medicines.”

The approval couldn’t come too soon. J&J is facing the near-term loss of patent protection on Zytiga, which is sold for metastatic prostate cancer.

“This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence. “In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public.”

J&J spent $650 million in cash and offered another $350 million in milestones to bag Rich Heyman’s Aragon in 2013, just so it could have this drug.

Just days ago investigators spelled out some impressive data. Their pivotal trial hit a median MFS rate of 40.5 months vs 16.2 months in the placebo group. “Secondary endpoints (TTM, PFS, and SymProg) were all significantly improved.

On the other hand you have Pfizer, which posted an impressive 21.9-month improvement  in metastasis-free survival for prostate cancer — 36.6 months vs 14.7 months [P < .0001] — for Xtandi as well as time to first use of new antineoplastic therapy (39.6 mo vs 17.7 mo [P < .0001]) and time to PSA progression (37.2 mo vs 3.9 mo).

J&J can now get a head start in the field, looking to score some blockbuster revenue.

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 51,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

Visit Endpoints Careers ->