The US Food and Drug Administration (FDA) will review Gilead Sciences’ new drug application (NDA) for idelalisib, an oral inhibitor of PI3K delta, to treat refractory indolent non-Hodgkin’s lymphoma (iNHL).
FDA has already granted a standard review for the iNHL NDA with a target review date under the prescription drug user fee act (PDUFA) of 11 September 2014.
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The NDA was based on a single arm Phase II trial evaluating idelalisib in patients with iNHL that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy.
Following the submission of NDA for iNHL, FDA also granted idelalisib a breakthrough therapy designation for relapsed chronic lymphocytic leukemia (CLL).
Idelalisib is an investigational, highly selective oral inhibitor of phosphoinositide 3-kinase (PI3K) delta. It is currently being developed both as a single agent and in combination with approved and investigational therapies.
According to the company, PI3K delta signalling is important for the activation, proliferation, survival and trafficking of B lymphocytes and is hyperactive in many B-cell malignancies.
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By GlobalDataGilead Sciences’ clinical development programme for idelalisib in iNHL includes a study 101-09 in highly refractory patients and two Phase III studies of idelalisib in previously treated patients.
The development programme in CLL includes three Phase III studies of idelalisib in previously treated patients.
The combination therapy of idelalisib and the company’s novel spleen tyrosine kinase (Syk) inhibitor ‘GS-9973’, is also being assessed in a Phase II trial in patients with relapsed or refractory CLL, iNHL and other lymphoid malignancies.
Image: Micrograph of mantle cell lymphoma, a type of non-Hodgkin lymphoma. Photo: courtesy of Nephron.
