A U.S. FDA panel of independent experts beat back an effort by Pfizer (NYSE:PFE) to expand the patient population for its prostate cancer treatment Talzenna (talazoparib).
Members of the Oncologic Drugs Advisory Committee expressed concerns that the data wasn’t strong enough and the benefits in an expanded population could have been random.
Talzenna is currently approved in combination with Xtandi (enzalutamide) for individuals with castration-resistant prostate cancer that have the HRR gene mutation. Pfizer submitted an sNDA to have the drug used with Xtandi but regardless of genetic mutation.
An expanded indication would allow Pfizer to more than triple the number of people eligible for Talzenna, Bloomberg reported.
In a pivotal study that examined the combination vs. Xtandi alone, Pfizer said those in the combination saw their survival improve by nine months at the median and cut death risk by 20%. However, FDA reviewers said that the trial design made it unclear whether those without the HRR mutation actually improved with Talzenna added.
Although the committee voted unanimously that the evidence to support the sNDA was lacking, the FDA is not bound by advisory committee decisions.