AbbVie’s Venclyxto Receives the EC’s Approval for Patients with Newly Diagnosed Acute Myeloid Leukemia who are Ineligible for Intensive Chemotherapy

May 26, 2021 Auto Bot AbbVie, acute myeloid leukemia, AML, approval, EC, regulatory 0

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

Click here to­ read full press release/ article | Ref: Abbvie | Image: Pharma Live

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