Patients to be selected for treatment based on approved companion diagnostic.
AstraZeneca and Merck have officially announced the FDA approval of Lynparza, a treatment for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC) in combination with abiraterone and prednisone or prednisolone (abi/pred).
Currently, the medication combined with abi/pred is approved in multiple countries including the EU for adult patients with mCRPC in whom chemotherapy is not clinically indicated, regardless of biomarker status.
“There is a critical unmet need for new first-line treatment options for patients with BRCAm mCRPC, and this approval underscores the importance of BRCA testing at metastatic diagnosis,” said Dave Fredrickson, EVP, oncology business unit, AstraZeneca. “We look forward to bringing the benefit of this Lynparza combination to patients earlier in their treatment.”
Reference: FDA Approves LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC). June 1, 2023/Business Wire