Verastem Inc. submitted a new drug application to the U.S. Food and Drug Administration for duvelisib as a treatment for certain lymphomas.
Lymphoma is cancer that begins in infection-fighting cells of the immune system, called lymphocytes.
The application is seeking approval to treat chronic lymphocytic leukemia/small lymphocytic lymphoma that has returned or is resistant to treatment. It also seeks accelerated approval to treat follicular lymphoma that has returned or is resistant to treatment.
The application includes results from a phase 3 study for relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma as well as another phase 2 study, which had patients with double-refractory follicular lymphoma.
Verastem is expecting a potential U.S. approval decision for duvelisib in early 2019, said Robert Forrester, president and CEO of Verastem.
