FDA OKs Talzenna for specific type of breast cancer
The Food and Drug Administration has cleared Talzenna (talazoparib), a poly (ADP-ribose) polymerase inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer.
Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib, which will be marketed by Pfizer.
The FDA also gave the green light to Myriad Genetic Laboratories’ BRACAnalysis CDx test, which identifies patients with breast cancer with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib.
Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib, which will be marketed by Pfizer.
The FDA also gave the green light to Myriad Genetic Laboratories’ BRACAnalysis CDx test, which identifies patients with breast cancer with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib.