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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.
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.
Researchers also found that a subgroup of patients who had been hormone receptor-positive and converted to TNBC status responded especially well to the therapy.
Though the Phase II results from the I-SPY 2 trial showed a potential benefit of the regimen in the neoadjuvant setting, additional data are needed.
Merck and AstraZeneca's PARP inhibitor was reported previously to stave off disease progression, based on which supplemental new drug application was filed with the FDA.
The company's PD-L1 IHC 22C3 pharmDx identifies patients with non-small cell lung cancer who qualify for first-line monotherapy with pembrolizumab.
Preclinical studies showed that combining CUE-101 with an anti-PD1 checkpoint inhibitor could increase anti-tumor efficacy in advanced HPV-positive head and neck tumors.
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.