The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the combination of olaparib (Lynparza) and bevacizumab (Avastin) for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response (PR) to first-line platinum-based chemotherapy with bevacizumab.1
The designation is based on results from the pivotal phase III PAOLA-1 trial, in which the combination led to an investigator-assessed 41% reduction in the risk of disease progression or death compared with bevacizumab alone in this patient population (HR, 0.59; 95% CI, 0.49-0.72; P
Additionally, after a median follow-up of 22.9 months, the median progression-free survival (PFS) was 22.1 months and 16.6 months with the combination and bevacizumab alone, respectively.
Under the Prescription Drug User Fee Act, the FDA is expected to make a decision on the sNDA in the second quarter of 2020.
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