Tesaro At Attractive Valuation Ahead Of Key Regulatory Decisions
- Tesaro expects the FDA decision for its Rolapitant IV in October.
- The company moved ahead for EC decision on Zejula, plans to launch in Q4.
- Tesaro reported multifold increase in quarterly revenue on the back of strong Zejula performance.
Tesaro Inc. (NASDAQ:TSRO) recently received a major boost as the company reporting receiving the positive nod from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use for Zejula to be used as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response (CR) or partial response (PR) to platinum-based chemotherapy. This action will move the therapy forward to the European Commission for marketing authorization. The drug is already approved by the FDA and thus has good probability of receiving the marketing clearance in the EU as well. The potential approval will make the drug the first oral, once-daily poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor approved in Europe for use in patients regardless of BRCA mutation or biomarker status.
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