Lynparza’s Approval Favored in EU for mCRPC Patients with BRCA Mutations

Lynparza’s Approval Favored in EU for mCRPC Patients with BRCA Mutations
Lynparza (olaparib) has been recommended for approval in the European Union to treat men with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in BRCA1 and BRCA2, two DNA repair genes. The marketing authorization application is specific for men whose disease progressed after treatment that included a newer hormone therapy, such as Xtandi (enzalutamide) or Zytiga (abiraterone acetate). The positive opinion by the Committee for Medicinal Products for Human Use (CHMP) was based on a subgroup analysis of mCRPC patients with BRCA mutations from the Phase 3 PROfound trial (NCT02987543), showing that Lynparza was more effective than those two hormone therapies at delaying disease progression or death, and extending overall survival. Opinions released by the CHMP, an arm of the European Medicines Agency, are generally accepted by the European Commission, which makes the final decisions. “In the PROfound trial, Lynparza provided a significant clinical benefit to men with BRCA1/2-mutated metastatic castration-resistant prostate cancer,” Roy Baynes, MD, senior vice president and head of global clinical development, and chief medical officer at Merck Research Laboratories, said in a press release. Merck is known as MSD outside North America. “If approved, Lynparza could be transformative in the treatment paradigm, bringing an additional option to certain prostate cancer patients in the EU,” Baynes added. The recommendation follows Lynparza’s approval in the U.S. for a similar but expanded indication, including patients with mutations in the BRCA and ATM genes, also involved in DNA repair processes known as homologous recombination repair (HRR). Lynparza, an oral PARP inhibitor developed by AstraZeneca and 
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