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Tesaro, Clovis Rally on FDA Priority Review for Lynparza sNDA

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Shares of TESARO, Inc. (TSRO - Free Report) and Clovis Oncology (CLVS - Free Report) were up on Tuesday, after AstraZeneca plc (AZN - Free Report) and partner Merck (MRK - Free Report) announced that the FDA has granted priority review to their regulatory application looking for label expansion of its PARP inhibitor, Lynparza, in the first-line setting for advanced ovarian cancer.

Notably, TESARO and Clovis market PARP inhibitors, Zejula and Rubraca, respectively. Both these companies are also developing the respective drugs, Zejula and Rubraca, as a first-line maintenance treatment for advanced ovarian cancer.

While TESARO gained 8.4%, Clovis was up 5.4% on Nov 13. However, so far this year, shares of TESARO and Clovis’ have lost 64.7% and 77.6%, respectively, compared with the biotech industry’s 19.4% decline.

The supplemental new drug application (sNDA) is looking for approval of Lynparza, as maintenance treatment in newly-diagnosed advanced ovarian cancer patients with BRCA mutation who have achieved complete or partial response, following first-line standard platinum-based chemotherapy. A decision from FDA is expected in the first quarter of 2019.

In fact, Lynparza’s sNDA is the first regulatory application in the PARP inhibitor segment seeking label expansion in first-line maintenance setting.  

The three approved PARP inhibitors at present compete in the second-line maintenance setting for ovarian cancer, irrespective of BRCA mutation and third or later line setting in BRCA-mutated ovarian cancer.

Successful development of these drugs in first-line setting is likely to improve sales for each. This is because first-line setting represents the largest addressable ovarian cancer patient population and only three drugs compete in the PARP inhibitor segment. Moreover, data from AstraZeneca’s phase III SOLO-1 study, which evaluated Lynparza in ovarian cancer as first-line maintenance, showed that duration of progression free survival in first-line is significantly higher than in recurrence setting. This suggest better acceptance of PARP inhibitors in first-line setting.

Meanwhile, on their third quarter earnings call, TESARO has stated that market share of PARP inhibitors’ in the ovarian cancer market has stagnated. Thus, label expansion in first-line setting might be a way to boost market share in the highly crowded advanced ovarian cancer market.

A phase III study — PRIMA — is evaluating Zejula monotherapy for treating advanced ovarian cancer in first-line maintenance setting. In the second quarter, TESARO has completed enrolment in the study and the top-line data is expected in 2019. A phase III study, ATHENA, is currently enrolling patients and evaluating Rubraca in combination with Bristol-Myers’ Opdivo in similar indication. Both these studies evaluate the therapies in ovarian cancer irrespective of BRCA mutation, which represents a larger patient population than BRCA-mutant ovarian cancer patients in Lynparza’s SOLO-1 study.

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AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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