The U.S. Food and Drug Administration (FDA) recently took action to speed the approval of AbbVie’s Venclexta tablets, which is the world’s first BCL-2 inhibitor for relapsed/refractory chronic lymphocytic leukemia patients who have 17p deletion.
In the company’s phase-two clinical study involving patients who have 17p deletion, the new BCL-2 inhibitor showed an 80 percent overall response rate. As of today, the inhibitor has already received approval as a single agent.
"The FDA's approval of Venclexta marks a major milestone for our company, and more importantly for the patients diagnosed with relapsed/refractory CLL who harbor the 17p deletion," Richard Gonzalez, CEO of AbbVie, said. "BCL-2 inhibition is a novel mechanism which brings a new treatment option to patients who need additional therapies."
These new tablets provide an important new treatment option specifically for patients who have a particularly challenging kind of CLL.
"The approval of Venclexta as a first-in-class BCL-2 inhibitor gives physicians an important option for the treatment of relapsed/refractory CLL harboring the 17p deletion," Michael Severino, chief scientific officer of AbbVie, said. "With the efficacy observed in this patient population, Venclexta has the potential to be an important and new therapy, advancing our efforts to bring novel treatment options to patients with this type of cancer."
