AbbVie and Roche’s Venclexta (venetoclax) Receive the US FDA’s Approval for Acute Myeloid Leukemia

 AbbVie and Roche’s Venclexta (venetoclax) Receive the US FDA’s Approval for Acute Myeloid Leukemia

AbbVie and Roche’s Venclexta (venetoclax) Receive the US FDA’s Approval for Acute Myeloid Leukemia

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 ­to­ read full press release/ article | Ref: Abbvie & Roche | Image: Leukemia & Lymphoma Society

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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