Shots:

• The approval is based on P-III VIALE-A and P-Ib M14-358 studies. The P-III study involves assessing Venclyxto + azacitidine in patients with newly diagnosed AML who were ineligible for intensive CT and demonstrated OS (14.7mos. vs 9.6mos.)- CCCR (66.4% vs 28.3%)- CR (36.7% vs 17.9%)
• The P-Ib M14-358 trial involves assessing in Venclyxto + azacytidine or decitabine in patients with newly diagnosed AML who were ineligible for intensive CT and showed CR+CRi rate (74%)- 30-day mortality rate (6.5%)
• In Apr’2021- Venclyxto + hypomethylating agents receive CHMP’s positive opinion for MAA to treat newly diagnosed AML patients who are ineligible for intensive CT

  Ref: Abbvie | Image:abbvie