Olaparib is the first PARP inhibitor approved in China for first-line maintenance treatment of germline and somatic BRCA mutated gynecological cancers.
The company is using the test to direct patient enrollment and treatment stratification in a trial of pembrolizumab (Keytruda) combination treatments.
This is the first anti-PD-1 drug approved for front-line treatment of advanced and unresectable, recurrent head and neck cancer in the EU.
Promega's microsatellite instability technology will be used to develop an on-label, solid tumor companion diagnostic for pembrolizumab.
The European Commission will review CHMP's recommendation and is slated to issue a final decision regarding marketing authorization later this year.
In KEYNOTE-522, early-stage TNBC patients on the immunotherapy and chemotherapy combination benefitted regardless of their PD-L1 expression status.
The assay was developed in partnership with Merck and is intended as a companion diagnostic for that firm's anti-PD-L1 immunotherapy.
Findings from three Phase III clinical trials suggest that PARP inhibitors may prolong disease-free survival in some advanced ovarian cancer patients without BRCA1/2 mutations.
Although the FDA has already approved the regimen in this indication after seeing its impact on progression-free survival, the latest data speaks to its impact on survival.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.