Tesaro, Inc. TSRO announced that the FDA has granted Fast Track designation to its pipeline candidate, niraparib, for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Tesaro has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA. The company plans to complete the submission during the fourth quarter of 2016.
The FDA’s Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious conditions and address unmet medical needs.
As part of the Fast Track program, the FDA allows for the submission of completed portions of an NDA on an ongoing or rolling basis. Tesaro is also planning to submit a Marketing Authorisation Application (MAA) for niraparib with the European Medicines Agency (EMA) in the fourth quarter.
We note that Tesaro is currently evaluating niraparib in four ongoing trials – a phase III trial, NOVA, in patients with platinum-sensitive, recurrent ovarian cancer; a phase III trial, PRIMA, in patients with first-line ovarian cancer; a registrational phase II trial, QUADRA, in patients with ovarian cancer; and a phase III trial, BRAVO, in patients with BRCA-positive breast cancer.
The company plans to present data from NOVA at a medical summit next month. The trial enrolled more than 500 patients with recurrent ovarian cancer, who were in response to their most recent platinum-based chemotherapy.
We note that the FDA approved Tesaro’s first commercial product, Varubi, for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in Sep 2015.
Tesaro currently carries a Zacks Rank #3 (Hold). Investors interested in the healthcare sector may consider stocks like ArQule Inc. ARQL, Pacira Pharmaceuticals PCRX and ANI Pharmaceuticals ANIP. While Pacira and ANI Pharma sport a Zacks Rank #1 (Strong Buy), ArQule is a Zacks Rank #2 (Buy) stock.
