The European Medicines Agency’s (EMA) advisory body, the Committee for Medicinal Products for Human Use (CHMP), gave a positive opinion in favour of approving AstraZeneca’s (AZN) Lynparza (olaparib).
AstraZeneca is looking get Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor, approved as a monotherapy for the maintenance treatment of adults suffering from platinum sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer. These adults are in complete or partial response to platinum-based chemotherapy.
We note that though the European Commission, which will be rendering a final decision on the approval status of Lynparza, is not bound to follow the CHMP's decision, it generally does so.
The CHMP’s decision comes on the basis of results from a phase II study evaluating the efficacy and safety of Lynparza in comparison to placebo. Results from the study revealed that progression free survival was prolonged in patients under Lynparza (11.2 months) compared to those under placebo (4.3 months).
We are encouraged by the CHMP’s positive opinion on the approval of Lynparza. The candidate’s fate was however not that good in the U.S. In Jun 2014, AstraZeneca announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against the approval of the oncology candidate (read more: AstraZeneca's Olaparib Fails to Impress FDA Panel).
A final decision on the approval status of the candidate in the U.S. is expected by Jan 3, 2015. On approval, Lynparza is expected to be the first PARP inhibitor to hit the EU, Iceland, Norway and Liechtenstein for the treatment of platinum sensitive relapsed BRCA-mutated high grade serous ovarian cancer.
We note that Clovis Oncology’s (CLVS) rucaparib is another PARP inhibitor being developed for the treatment of platinum-sensitive ovarian cancer patients.
AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Allergan (AGN) and Regeneron Pharmaceuticals, Inc. (REGN). Both stocks hold a Zacks Rank #2 (Buy).
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