Shots:

• The approval is based on P-lll VIALE-A & VIALE-C studies and updated data from the P-Ib M14-358 and the P-I/II M14-387 studies. The P-III studies involve assessing of Venclexta (400mg & 600mg- qd) + azacitidine & LDAC vs PBO + azacitidine & LDAC in 431 & 211 people with previously untreated AML who are ineligible for intensive CT respectively
• VIALE-A results: Reduction in the risk of death (34%)- m-OS (14.7 vs 9.6mos.)- CR rate (37% vs 18%); CR+CRh rate (65% vs 23%)- median duration (7.6 mos.). VIALE-C results: CR rate (27% vs 7.4%); DOCR (11.1mos. vs 8.3mos.); m-OS (7.2mos. vs 4.1mos.). In 2018- the US FDA granted accelerated approval for AML
• This is the second time that Venclexta has been reviewed under the FDA’s new RTOR and Assessment Aid pilot program. Additionally- the FDA has granted five BTD for Venclexta- two of which are for people with previously untreated AML ineligible for intensive CT

Source 1- Source 2 ­ 

Ref: Abbvie & Roche | Image: Roche