Shares of Verastem Oncology (NASDAQ:VSTM) are still gaining ground in Tuesday’s pre-market session after the cancer specialist won its first approval from US regulators for its drug to treat three forms of blood cancer.
The US Food and Drug Administration has given the green light for its drug Copiktra, which is also known as duvelisib, to fight chronic lymphocytic leukemia, follicular lymphoma as well small lymphocytic lymphoma in patients who relapse and have previously tried two prior therapies.
Investors welcomed the news and sent Verastem shares up 4% to $9.30 before Tuesday’s opening bell.
“Copiktra is a significant addition to physicians’ treatment armamentarium that I believe will address an unmet need for patients who have limited options once they have progressed after two prior therapies,” said Dr. Ian Flinn, director of the Lymphoma Research Program at Sarah Cannon Research Institute and lead investigator of the Dynamo and Duo studies, evaluating Copiktra.
Lymphoma is the most common blood cancer and chronic lymphocytic leukemia and small lymphocytic lymphoma are common types of non-Hodgkin lymphomas. There are as many as 681,000 people living with non-Hodgkin lymphoma in the US alone and many of these patients will eventually relapse or fail to respond to initial treatments.
Copiktra is the only gamma-delta inhibitor on the market for relapsed cases of chronic lymphocytic leukemia and small lymphocytic lymphoma.
The drug will be available in the US immediately, but will carry a boxed warning as it comes with the risk of infection, diarrhea, colitis, skin reactions and pneumonitis.