The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for idelalisib, a targeted, oral inhibitor of PI3K-delta, for the treatment of refractory indolent non-Hodgkin lymphoma (NHL). The FDA has granted a standard review for the NDA, with a target review date of September 11, 2014.
The application was supported by a single-arm phase II study (Study 101-09) evaluating idelalisib in patients with indolent NHL that is refractory to rituximab (Rituxan) and to alkylating agent–containing chemotherapy. Following the NDA submission for indolent NHL, the FDA granted idelalisib a Breakthrough Therapy designation for relapsed chronic lymphocytic leukemia (CLL). An NDA for idelalisib for the treatment of CLL was submitted in December 2013. ■