Verastem Inc. said the U.S. Food and Drug Administration granted an orphan drug designation to Copiktra for the treatment of a rare and aggressive type of cancer.
Verastem's stock price was up 10.3% to $1.24 as of 2:37 p.m. ET on Oct. 3.
The designation for Copiktra covers T-cell lymphoma, a rare type of cancer that begins in white blood cells called T lymphocytes, which help the body's immune system.
Copiktra, or duvelisib, is already approved by the FDA to treat two types of blood cancer in adults, chronic lymphocytic leukemia/small lymphocytic lymphoma and follicular lymphoma.
Verastem is evaluating the drug in phase 2 trial Primo as a treatment for patients with relapsed or refractory peripheral T-cell lymphoma.
Needham, Mass.-based Verastem granted French pharmaceutical giant Sanofi rights to develop and commercialize Copiktra for all cancer indications in Russia and the Commonwealth of Independent States, Turkey, the Middle East and Africa.
The FDA's orphan drug program is for medicines that can treat rare diseases or disorders affecting fewer than 200,000 people in the U.S. With the designation, Verastem's treatment will be eligible for certain incentives, including tax credits for covering clinical trial expenses, prescription drug user fee waivers and a seven-year market exclusivity after approval.
