Venclexta Receives New Indication
November 21, 2018 – The U.S. FDA has approved a new indication for Venclexta® (venetoclax) tablets, manufactured by AbbVie. The drug is now indicated for use in combination with azacitidine, decitabine, or low-dose cytarabine to treat newly diagnosed acute myeloid leukemia (AML) in adults who are at least 75 years of age or who have comorbidities that preclude the use of intensive induction chemotherapy.
Almost half of all patients diagnosed with AML are not able to undergo intensive chemotherapy. These patients typically face a poor prognosis in the face of an aggressive blood cancer. Median survival for AML patients who cannot undergo intensive chemotherapy is five to 10 months.
In clinical studies, 37% of patients treated with Venclexta and azacitidine achieved complete remission lasting a median five-and-half months. More than half (54%) of patients who received Venclexta and decitabine experienced complete remission, which lasted a median 4.7 months. For patients who received Venclexta and low-dose cytarabine, 24% had complete remission that lasted a median six months. The FDA granted Venclexta accelerated approval for its new indication based on the results of these studies. Continued approval may require verification and description of clinical benefit in confirmatory trials.
Recommended dosing under the new indication requires a ramp-up schedule in which the patient begins with 100mg of Venclexta on Day One. The patient then takes 200mg on Day Two, and 400mg on Day Three. On Day Four, patients who take Venclexta with azacitidine or decitabine will continue with 400mg of Venclexta as the maintenance dose, while patients who take Venclexta with low-dose cytarabine will move to a maintenance dose of 600mg. Treatment should continue until disease progression or unacceptable toxicity. Venclexta is available in 10mg, 50mg, and 100mg tablets, and should be taken once per day with a meal and water.