The FDA center of excellence has engaged the technology vendor to incorporate real-world evidence into regulatory decision-making for precision oncology treatments.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.
The FDA and its pediatric oncology drugs advisory committee heard at a recent meeting how the drug is allowing some to live longer than expected, without toxicities.
