Print“We believe idelalisib could become an important new therapy for patients who have limited treatment options.”
Gilead Sciences reached a major milestone in its expansion into cancer therapeutics with the submission to the U.S. Food and Drug Administration of a new drug application for idelalisib, its investigational, targeted treatment for slow-growing non-Hodgkin’s lymphoma.
If approved, idelalisib would be Gilead’s first approved cancer therapy, the first therapy to target phosphoinositide 3-kinase delta, a protein that is critical for the activation, proliferation, and survival of B lymphocytes, and the first new class of therapy approved for slow growing, or indolent non-Hodgkin’s lymphoma in more than a decade. Gilead is also testing the drug against chronic lymphocytic leukemia.
Indolent lymphomas run a relapsing course after therapy and lead ultimately to life-threatening complications, such as serious infections and bone marrow failure. Most patients are diagnosed at an advanced stage of disease, and median survival from time of initial diagnosis for patients with the most common form of indolent non-Hodgkin's lymphoma, follicular lymphoma, is eight to ten years. The outlook for refractory indolent non-Hodgkin’s lymphoma patients is significantly poorer.
Gilead supported its new drug application with data from a mid-stage trial of idelalisib in 125 patients who did not respond to Genentech’s rituximab and chemotherapy. The company presented an interim analysis of that data in June. The analysis showed that patients taking only idelalisib achieved an overall response rate of 53.6 percent, with a response that lasted a media 11.9 months.
“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,” says Gilead's Chairman and CEO John Martin.
Gilead added idelalisib to its portfolio with the purchase of Calistoga Pharmaceuticals in February 2011 for $375 million upfront and up to $225 million in milestones. The drug, then known as CAL-101, added depth to a portfolio that the company was already expanding with its oncology-focused acquisitions of CGI Pharmaceuticals and Arrestor Biosciences and its cardiovascular-focused acquisitions of Myogen and CV Therapeutics.
September 12, 2013
http://www.burrillreport.com/article-gilead_seeks_approval_for_its_first_cancer_therapy.html
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