Tesaro, Clovis Rally on FDA Priority Review for Lynparza sNDA

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Shares of TESARO, Inc.TSRO and Clovis Oncology CLVS were up on Tuesday, after AstraZeneca plc AZN and partner Merck MRK 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.

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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