Tesaro plans speedy response to CRL for nausea drug
- The Food and Drug Administration wants more information on the manufacturing practices related to Tesaro's drug rolapitant IV, and won't decide on the treatment's approval status until it gets it.
- In a Jan. 11 statement, the cancer therapies provider said it received a complete response letter (CRL) for its anti-nausea and anti-vomitting drug for patients receiving chemotherapy. Varubi, the oral formulation of rolapitant, is already available as an add-on to antiemetics. Tesaro hopes for approval for the intravenous formulation in the first half of 2017.
- The letter asked for further details on two plants that Tesaro said would manufacture the drug in its New Drug Application. "Potential deficiencies" at the first site pushed the company to employ the second, and the FDA wants to know more about the methods used to compare the quality of the products from both facilities.
The nausea and vomiting that goes along with chemotherapy is unpleasant and debilitating, and can make treating the disease more arduous. With nearly 1.7 million new cases of cancer expected to be the final tally in the U.S. during 2016, controlling its negative side effects has become a focus for many pharmaceutical companies.
As such, the research firm Technavio anticipates global markets for chemotherapy-induced nausea and vomiting (CINV) drugs to reach $2.1 billion by 2021, with a compound annual growth rate of 6% over the next five years.
Tesaro made a point to say that the FDA raised no concerns over the efficacy and safety profile of rolapitant IV and did not require any additional clinical trials.
CINV "remains a significant unmet need, with more than half of patients treated with [vomit-inducing] chemotherapy experiencing this debilitating side effect," Mary Lynne Hedley said in a Jan. 11 statement.
While oral rolapitant, a neurokinin 1 receptor antagonist (NK-1 RA), is already available as Varubi, adding an IV formulation increases the options for physicians and patients. Tesaro's first marketed product, Varubi brought in $2.8 million in net product revenue during the third quarter, according to the company's most recent 10-K filing with the Securities and Exchange Commission.
Rolapitant faces competition, though. Heron Therapeutics, for instance, received approval in October for Sustol, an extended release formulation of granisetron. The drug has indications for acute- and delayed-release CINV, in combination with other antiemetics. This week, Heron submitted Cinvanti, an IV formulation of the NK-1 antagonist aprepitant, which would add a second and complementary drug to its CINV portfolio.
- Tesaro Statement
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