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The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.
The company's PD-L1 IHC 22C3 pharmDx identifies patients with non-small cell lung cancer who qualify for first-line monotherapy with pembrolizumab.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.
The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.
AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.
The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.
The company is using the test to direct patient enrollment and treatment stratification in a trial of pembrolizumab (Keytruda) combination treatments.
Clinicians can use the PD-L1 IHC 22C3 pharmDx assay to help identify head and neck squamous cell carcinoma patients for treatment with Merck's Keytruda in Europe.