FDA has approved BRACAnalysis CDx to be used by healthcare professionals to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are eligible for treatment with Pfizer’s PARP inhibitor, Talzenna (talazoparib).
A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.
