Datapoint: FDA Approves Second PARP Inhibitor in Prostate Cancer

The FDA on June 20 approved Pfizer’s Talzenna (talazoparib) for the treatment of homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) in adult patients, in combination with Xtandi (a Pfizer-Astellas joint venture). The win represents a broader patient population than AstraZeneca and Merck’s Lynparza (olaparib), which just weeks ago became the first PARP inhibitor to receive FDA approval to treat mCRPC. Lynparza, in combination with Johnson & Johnson’s Zytiga, is approved to treat mCRPC patients with BRCA-mutated tumors, which accounts for about 10% of the patient population. HRR mutations, meanwhile, make up about 25% of prostate cancer cases. For the treatment of metastatic prostate cancer, Lynparza currently holds preferred status for 15% of all insured lives under the pharmacy benefit, growing to 47% with utilization management restrictions applied.

SOURCE: MMIT Analytics, as of 6/23/23

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