Pfizer Gains Priority Review For Breast Cancer Drug, Can It Succeed?

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.

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