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 ...

The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in patients with prostate cancer who do not carry HRR mutations.

The FDA approved the poly ADP ribose polymerase (PARP) inhibitor in June 2023 in combination with enzalutamide for men with ...

Pfizer hopes a unique life-extension benefit for its Talzenna can serve to further expand the drug’s already broadest-in-class U.S. label in prostate cancer. Following an FDA approval in 2023 ...

This release contains forward-looking information about Pfizer Oncology, TALZENNA and XTANDI, including their potential benefits, the TALAPRO-2 results and plans to share the results with global ...

Astellas and Pfizer's Xtandi plus ADT showed a decrease in mortality risk in a metastatic hormone-sensitive prostate cancer ...

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K.

Pfizer Inc. announced positive results from the phase 3 TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an ...

TALZENNA + XTANDI is the first PARP inhibitor plus ARPI combination to demonstrate statistically significant and clinically meaningful improvement in overall survival (OS) in patients with ...

Also Read: Pfizer/Astellas Tout Encouraging Data From ... up (52.5 months), the median OS in cohort 1 was 45.8 months with Talzenna in combination with Xtandi and 37.0 months with Xtandi and ...