Pfizer obtains priority review for talazoparib in treating patients with germline BRCA-mutated breast cancer, with FDA decision date by December 2018.
Treatment with talazoparib in BRCA-mutated breast cancer reduced the risk of disease progression by 46%.
If talazoparib is approved by the FDA it will have to go up against other competing drugs for the same indication such as Lynparza, Zejula, and Rubraca.
Pfizer’s acquisition of Medivation also gave it Xtandi, which produced alliance revenues of $590 million in 2017.
Pfizer is expecting an FDA decision date for an expanded label on Xtandi in non-metastatic castration resistant prostate cancer by July.
Recently, Pfizer (PFE) announced that it had received priority review for its breast cancer drug talazoparib. This priority review will allow the drug to gain approval sometime near the end of the year, which is a huge positive. There will be a host of competitors that will not make it an easy market to get into. However, Pfizer hasn’t done all that bad since its acquisition of Medivation which gave it talazoparib. That’s why I believe Pfizer is a buy.
Priority Review On The Way
With the FDA priority review for talazoparib, it will speed up the approval process. The FDA decision for approval is now expected by December of 2018. The reason for the acceptance of the NDA filing and for the priority review designation being given was because of positive results from the EMBRACA trial. This phase 3 study recruited a total of 431 patients with an inherited BRCA mutation and locally advanced or metastatic triple negative breast cancer (TNBC) or hormone receptor-positive (HR+)/HER2-breast cancer. The study met its primary endpoint of progression-free survival (PFS). The trial was set up to test talazoparib versus standard of care chemotherapy. It was noted that patients treated with talazoparib had a median PFS of 8.6 months, compared to only 5.6 months for those treated with chemotherapy. This means that treatment with talazoparib resulted in a 46% reduction in the risk of disease progression. Now, I’m happy to say that I like the results from this study. Why are these results so significant? That’s because this trial tested talazoparib versus investigator’s choice of chemotherapy. That means those patients on the chemo were given whatever chemotherapy their investigator deemed would be most sufficient. Despite the ability investigator’s choice of chemotherapy, talazoparib still performed better in PFS. Another impressive observation was that talazoparib was able to allow a greater proportion of the patients to achieve a partial or complete response rate (objective response rate – ORR) of 62.6%. On the other hand, chemotherapy only saw an ORR of 27.2%. Along with the NDA that was just accepted by the FDA for priority review, the EMA has also already accepted the application for talazoparib.