publication date: Jul. 20, 2018

FDA spells out rules for new endpoint: Metastasis-free survival

By Paul Goldberg

It’s official, FDA is recognizing a new endpoint that seems especially well suited for prostate cancer: metastasis-free survival, or MFS for short.

Agency officials wrote a “perspective” piece for The New England Journal of Medicine, describing the characteristics of the endpoint, how it was developed, and how it was being used.

The piece was written by FDA Oncology Center of Excellence officials Julia Beaver, Paul Kluetz, and Richard Pazdur and published in the June 28 edition of NEJM.

“Whereas radiographic progression-free survival has been standardized as an endpoint in metastatic settings, there was previously no earlier end point for nmCRPC trials,” the article states. “The FDA has now recognized that a prolonged delay in development of metastatic disease is an objective and clinically relevant measure. Future agents may be approved on the basis of metastasis-free survival only if substantial effects on this transition are demonstrated and the safety profile is acceptable for a medication taken long-term.”

The article noted that earlier this year, on Feb. 14, the agency approved one prostate cancer drug—apalutamide (Erleanda), an androgen receptor inhibitor—based on MFS.

The agent was approved for treatment of patients with non-metastatic castration-resistant prostate cancer. Sponsored by Janssen Pharmaceutical Companies, Erleada was approved based on the SPARTAN trial.

On July 13, FDA approved another agent, enzalutamide (Xtandi), based on the same endpoint. Sponsored by Pfizer Inc. and Astellas Pharma US Inc., Xtandi was approved based on the PROSPER trial.

Xtandi was approved for patients with castration-resistant prostate cancer. This broadens the indicated patient population to include patients with both non-metastatic … Continue reading FDA spells out rules for new endpoint: Metastasis-free survival

To access this members-only content, please log in.
Institutional subscribers, please log in with your IP.
If you're not a subscriber why not join today?
To gain access to the members only content click here to subscribe.
You will be given immediate access to premium content on the site.
Click here to join.

Copyright (c) 2019 The Cancer Letter Inc.