Six months after England’s National Institute for Health and Care Excellence (NICE) spurned Pfizer’s breast cancer treatment Talzenna (talazoparib) because it was not cost effective, the agency has reversed course following the company’s offer to slash the price.
EC Approves Pfizer’s TALZENNA®with XTANDI® for Prostate Cancer
The PARP inhibitor class is welcoming its second FDA approval in prostate cancer in the span of several weeks. The new approval, for Pfizer, is broader than the first but still limited.
The FDA has approved talazoparib (Talzenna) plus enzalutamide (Xtandi)
NEW YORK--(BUSINESS WIRE)--Pfizer (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). This approval is based on the statistically significant and clinically meaningful radiographic progression-free survival (rPFS) data from the Phase 3 TALAPRO-2 trial, which demonstrated a 55% reduction in the risk of disease progression or death in patients with mCRPC with prospectively identified HRR gene mutations (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C) treated with TALZENNA plus XTANDI vs placebo plus XTANDI (HR 0.45; 95% CI, 0.33–0.61; p<0.0001).
Pfizer may be the last major oncology player to put a wager on a PARP inhibitor in prostate cancer, but the New York pharma appears to have a winning regimen, partly thanks to its Astellas-partnered stalwart Xtandi.
TAIPEI and SAN DIEGO, Oct. 31, 2022 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced today that their first patient has been successfully dosed, in a phase I clinical study evaluating the combined treatment with Senhwa's Pidnarulex, the 2019 PCF-Pfizer Global Challenge Awards winner and Pfizer's PARP inhibitor, Talazoparib (Talzenna), in patients with metastatic castration-resistant prostate cancer(mCRPC). The study will be conducted by Peter MacCallum Cancer Centre (PMCC), Senhwa's clinical partner in Melbourne, Australia.
Early data from the Phase III TALAPRO-2 study showed Talzenna (talazoparib), Pfizer’s oral PARP inhibitor, met its primary endpoint in metastatic castration-resistant prostate cancer patients, the company announced Tuesday.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide) compared to placebo plus XTANDI in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared with placebo plus XTANDI. The results of the primary endpoint exceeded the pre-specified hazard ratio of 0.696.
Artios initiates Phase 2 study of Pol? Inhibitor ART4215