The latest regulatory news and FDA approvals.
The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.
The program, called Project Facilitate, aims to help oncologists request access to investigational drugs but may only simplify part of the process.
This is the third drug the agency has approved with a pan-cancer indication.
The company is on track to submit Guardant360 to the FDA in the third quarter, but also expects to see pan-cancer reimbursement much sooner.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.