Posted by Michael Wonder on 21 Sep 2020
Lynparza recommended for approval in the EU by CHMP for BRCA mutated metastatic castration-resistant prostate cancer
21 September 2020 - Only PARP inhibitor to improve overall survival versus new hormonal agent treatments in advanced prostate cancer.
AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair gene mutations.
The CHMP of the European Medicines Agency based its positive opinion on a subgroup analysis of patients with BRCA1/2 mutations from the PROfound Phase 3 trial. The primary results from the trial were published in The New England Journal of Medicine in May 2020.
