LLS Welcomes FDA Approval of Venclexta to Treat Certain Chronic Lymphocytic Leukemias

LLS Welcomes FDA Approval of Venclexta to Treat Certain Chronic Lymphocytic Leukemias

The Leukemia & Lymphoma Society (LLS) welcomed the recent approval of Venclexta (venetoclax) to treat people with a severe form of chronic lymphocytic leukemia (CLL). The drug, whose development and testing the LLS supported, was approved by the U.S. Food and Drug Administration (FDA) on April 11 for CLL patients with 17p deletion, an abnormality in chromosome 17, who have failed to respond to at least one other therapy.

An estimated 126,000 or more people in the U.S. have been diagnosed with CLL, a typically slow-progressing blood cancer that begins in the bone marrow. Among those unresponsive to treatment or who have relapsed, some 30 percent have 17p deletion.

Venclexta is an oral medicine that targets the B-cell lymphoma 2 (BCL-2) protein, which is known to support cancer cell growth and is frequently overexpressed in CLL patients. The FDA approval was based in part on positive data from the Phase 2 clinical trial of the drug, with results published in The New England Journal of Medicine in the article, Targeting BCL2 with Venetoclax in Relapsed Chronic Lymphocytic Leukemia.”

Through its Specialized Center of Research (SCOR) grant program, the LLS has given over $15 million to research leading to the drug’s development since 2002. The research team was led by Jerry Adams, PhD, from the Walter and Eliza Hall Institute on Medical Research in Melbourne, Australia.

“We are very gratified that research we have long supported is yielding a new treatment for patients with CLL,” Louis J. DeGennaro, president and chief executive officer of LLS, said in a press release. “Our experience and investment in the blood cancers allows us to think big and boldly about new therapies. We are also presently supporting research investigating venetoclax as a therapy for patients with acute lymphoblastic leukemia (ALL) and mantle cell lymphoma (MCL).”

The LLS is also funding ongoing research into the effectiveness of venetoclax in inhibiting BCL-2 in acute myeloid leukemia (AML) patients, led by Anthony Letai, MD, PhD, at the Dana-Farber Cancer Institute. The work has shown encouraging results, the society said in the release, and Dr. Letai’s is also developing ways of predicting which tumors may be sensitive to venetoclax. The FDA granted Breakthrough Therapy Designation to venetoclax, in combination with other therapies, as an investigative drug for untreated AML patients not eligible for standard care (high-dose chemotherapy).

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