Bristol Myers Squibb is hoping that the durable responses seen with the combined immunotherapy drugs will convince doctors to prescribe it for their patients.
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 accelerated approval was based on data from the TRITON2 trial involving metastatic patients with BRCA mutations and homologous recombination deficiency.
In KEYNOTE-355, patients with PD-L1 expression greater than or equal to a combined positive score of 10 had improved progression-free survival on first-line Keytruda and chemo.
The survival data from the Phase III SOLO2 trial confirms to experts that olaparib should be the standard of care maintenance therapy for patients in this setting.
The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.
