FDA Grants Priority Review to Lynparza as Treatment for Mutated Metastatic Castration-resistant Prostate Cancer

FDA Grants Priority Review to Lynparza as Treatment for Mutated Metastatic Castration-resistant Prostate Cancer
Note: This story was updated May 21, 2020, to note that Merck is known as MSD outside the U.S. and Canada, not as EMD Serono. The U.S. Food and Drug Administration (FDA) has granted priority review status to an application to extend the use of the oral therapy Lynparza (olaparib) to men with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in DNA repair genes, including BRCA or ATM, and who have failed prior treatment with a new hormone therapy. Priority review status cuts the time to six months for the FDA to make its decision, from the typical 10 months under standard review. A final resolution on the supplemental new drug application is expected for the second quarter of this year, according to a press release. The application from AstraZeneca and Merck (known as MSD outside the U.S. and Canada) was based on positive results from the Phase 3 PROfound trial (NCT02987543). The study compared the efficacy and safety of Lynparza to that of Xtandi (enzalutamide; by Astellas and Pfizer Oncology) or Zytiga (abiraterone; by Janssen) in mCRPC patients whose disease progressed while on these newer hormone treatments, and whose tumors carried mutations in one of 15 genes involved in the homologous recombination (HR) pathway of DNA repair. Tumors with this kind of mutation are more likely to respond to a class of anti-cancer medicines known as PARP inhibitors, which includes Lynparza. In the study, patients were treated with 300 mg twice daily of Lynparza, or the investigators’ choice of either Xtandi (160 mg daily) or Zytiga (1,000 mg daily, plus prednisone). Results presented last year at the ESMO Congress 2019, held in Barcelona, Spain, showed that Lynparza reduced the risk of death or cancer progression in a clinically
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