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FDA grants second breakthrough therapy designation to venetoclax for CLL
The FDA today granted breakthrough therapy designation to venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia, according to a press release from the drug’s manufacturer.
The FDA previously granted breakthrough therapy designation to venetoclax (AbbVie and Genentech/Roche) — an inhibitor of the B-cell lymphoma-2 protein — for single-agent treatment of patients with relapsed or refractory CLL who harbor the 17p deletion genetic alteration.
The new breakthrough therapy designation is based on an investigational study of venetoclax in combination with rituximab (Rituxan, Genentech) for patients with relapsed or refractory CLL. Rituximab already is approved for use in combination with fludarabine and cyclophosphamide for treatment of patients with CD20-positive CLL.
“This second breakthrough therapy designation for venetoclax granted by the FDA underscores the significant potential of this therapy in treating relapsed/refractory CLL patients, and reflects AbbVie’s commitment to providing breakthrough therapies for cancer patients,” Michael Severino, MD, executive vice president of research and development and chief scientific officer of AbbVie, said in the press release. “AbbVie will continue harnessing our collective expertise to accelerate efforts to bring new treatment options to patients battling this difficult to treat blood cancer.”