Gilead Submits NDA for a Novel Treatment of Indolent Non-Hodgkin's Lymphoma

Gilead is announcing that they have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for approval of idelalisib, an investigational, targeted, oral inhibitor of PI3K delta for the treatment of indolent non-Hodgkin's lymphoma.

Specifically, idelalisib is designed for patients with indolent non-Hodgkin's lymphomas that are refractory to rituximab and to alkylating agent-containing chemotherapy (common sense suggests this would refer to commonly prescribed drugs for indolent NHLs such as doxorubicin, such as can be found in the CHOP regimen).

Said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences:

Gilead is committed to advancing a pipeline of novel cancer therapies that have the potential to improve the lives of patients. Based on the rate and duration of response observed to date in this highly refractory iNHL patient population, we believe idelalisib could become an important new therapy for patients who have limited treatment options.

A new class of therapies

The NDA for idelalisib is supported by data from a single-arm, open-label Phase 2 study (Study 101-09) of 125 patients with indolent NHLs refractory to rituximab and to alkylating-agent-containing chemotherapy. Interim data analysis presented in June at the International Conference on Malignant Lymphoma in Lugano, Switzerland, demonstrated that single-agent idelalisib achieved an overall response rate of 53.6 percent, with a median duration response of 11.9 months.

Idelalisib is an investigational, targeted, highly selective oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein critical for the activation, proliferation and survival of B lymphocytes. PI3K delta signaling is hyperactive in many B-cell lymphomas and leukemias, and drives proliferation, survival and trafficking to lymphoid tissue. Idelalisib is being developed as a single agent and in combination with approved and investigational therapies.

If ultimately approved, Idelalisib would become the first PI3K delta targeted therapy approved for a blood cancer and the first in a new class of therapies approved for indolent NHLs in more than 10 years.

Source: MarketWatch