FDA ODAC -Lynparza (olaparib), PARP inhibitor, is only for metastatic castration-resistant PC patients whose tumors have a BRCA mutation.

[JRPnSD]

The FDA Oncologic Drugs Advisory Committee agreed with the agency’s forcefully stated view that Lynparza (olaparib), a PARP inhibitor, should be given only to metastatic castration-resistant prostate cancer patients whose tumors have a BRCA mutation.

Does anyone have more insight into this finding?

[Balsam01]

I think this may be misguided. While I was at Johns Hopkins, my MO there tried to recruit me into a trial using Olaparib claiming that it would set the disease back years perhaps with long-term remission. the only catch to me entering this trial was that my T had to be a lot higher than it was so I was rejected. I assumed that he knew what he was talking about so I think that waiting too late into a patient's disease progression may be merely adding months to a lifespan vs. the potential for years. I am double BRCA2--germline and somatic.

[BRCA2MX in reply to Balsam01]

This g+sBRCA2m+ , g+sATMm+, sFOXA1m+ guy agrees with your sense. PARPi's (as olaparib) are being used as maintenance therapies with other cancers and broadly under trials for many applications, even cancer preventatives for HRDm+ people/previvors. FDA may simply be reacting to the intense interest in (and marketing?) of PARPi's. MD's, especially MOs are still able to prescribe drugs off label (blessedly...) Stay tuned, especially in 5-10 years out.