FDA Reviewing Lynparza-bevacizumab as First-line Maintenance for Advanced Ovarian Cancer, Regardless of BRCA Status

FDA Reviewing Lynparza-bevacizumab as First-line Maintenance for Advanced Ovarian Cancer, Regardless of BRCA Status
The U.S. Food and Drug Administration (FDA) has agreed to review AstraZeneca and Merck's request to extend the indication of oral Lynparza (olaparib) as a first-line maintenance therapy in combination with bevacizumab for treating women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of their BRCA mutation status. Priority review was granted to the supplemental new drug application for the combo therapy, with a decision expected in the second quarter of this year, according to a press release. This status shortens the agency's decision to six months, instead of the 10 months typically taken under standard review. Submission was based on the results of the Phase 3 trial PAOLA-1 (NCT02477644), which compared adding
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