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NEW PRODUCT ANNOUNCEMENT
Yesterday, the FDA approved Pfizer’s Talzenna (talazoparib) for the treatment of adults with deleterious (or suspected) BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. The drug was approved in conjunction with Myriad Genetics’ BRACAnalysis CDx as a companion diagnostic, which will be a determinant for treatment eligibility. The approval is based on a trial of patients with at least 3 previous lines of systemic cytotoxic therapy. Patients showed a significant benefit in progression-free survival and overall response rate across all demographic categories. Talzenna is in a class of therapies known as PARP inhibitors. There are currently three other PARP inhibitors on the market – Lynparza (AZ), Rubraca (Clovis) and Zejula (Tesaro) – yet this is the first with a breast cancer indication. The others are performing trials or seeking approval at this moment.
US Bioservices will have access to dispense Talzenna. Pfizer is following their usual, broader SP network to support dispensing, which encompasses about 18 SPs. Pfizer expects to make this drug available for dispense in the coming days.
