AstraZeneca and Merck & Co. announced Wednesday that the FDA granted priority review to a marketing application seeking approval of Lynparza (olaparib) in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings. The companies noted that the agency's target review date for the filing is set for the first quarter of 2018.
According to AstraZeneca and Merck, this is the first submission for a PARP inhibitor outside ovarian cancer. Lynparza was first approved by the FDA in 2014 for the treatment of women with advanced ovarian cancer associated with defective BRCA genes. More recently, the regulator expanded clearance for the therapy, approving the switch to a new formulation consisting of two tablets twice-daily.
AstraZeneca and Merck noted that the latest submission is based on results from the Phase III OlympiAD trial, with the study showing that Lynparza was associated with a significant and clinically-meaningful improvement in progression-free survival compared to chemotherapy.
Earlier this year, AstraZeneca and Merck announced a global strategic collaboration to jointly develop and commercialise Lynparza, as well as the experimental MEK inhibitor selumetinib, for multiple cancer types.
For related analysis, see ESMO Spotlight: PARP Wars, and read KOL Views Results: Marketing departments may decide brewing battle of the PARPs in ovarian cancer, says leading oncologist.
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