The FDA has cleared AstraZeneca’s (AZN) Lynparza as a monotherapy for the maintenance treatment of adults suffering from deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been previously treated with three or more prior lines of chemotherapy. The drug was approved under the FDA's accelerated approval program.
The path to approval was, however, not easy. In Jun 2014, the FDA’s Oncologic Drugs Advisory Committee voted against the approval of this drug. The company was looking to get Lynparza approved as a maintenance treatment for patients suffering from platinum-sensitive relapsed ovarian cancer with the germline BRCA mutation. These patients were in complete or partial response to platinum-based chemotherapy.
In Jul 2014, AstraZeneca submitted a major amendment to the New Drug Application of Lynparza. The approval of the drug has been based on efficacy data from a single-arm, open-label phase II study in patients suffering from deleterious or suspected deleterious germline BRCA-mutated advanced cancer. Other Lynparza study data has also been taken into consideration.
AstraZeneca however mentioned in its press release that full review of data from either of two ongoing phase III studies (SOLO2 and SOLO3) is required to convert the current BRCA-mutated advanced ovarian cancer indication to a full approval. While results from the SOLO2 study are expected in 2015, results from SOLO3 are expected in 2019.
The U.S. approval of Lynparza comes close on the heels of the drug gaining EU approval. The drug was approved in the EU 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, who are in complete or partial response to platinum-based chemotherapy. Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor.
Our Take
AstraZeneca has received several regulatory approvals over the last few months including Duaklir Genuair (chronic obstructive pulmonary disease) and Moventig (opioid-induced constipation). We note that AstraZeneca is under severe pressure from generic competition in key franchises.
A key product, Nexium, which generated more than 15% of AstraZeneca’s total revenues last year, is also expected to go generic soon. The company’s pipeline needs to deliver significantly to offset these losses.
AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Amgen Inc. (AMGN), Allergan (AGN) and AbbVie Inc. (ABBV). While Amgen carries a Zacks Rank #1 (Strong Buy), Allergan and AbbVie hold a Zacks Rank #2 (Buy).
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