Genentech’s Venclexta (venetoclax) Receives FDA’s Accelerated Approval for Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML)

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• The accelerated approval is based on M14-358 (P-Ib) & M14-387 study (I/II) results assessing Venclexta (400mg qd) + azacitidine & decitabine & Venclexta (600mg qd) + LDAC (low-dose cytarabine) respectively in patients with 1L AML. or for those ineligible for intensive induction CT aged ≥60 yrs.
• M14-358 & M14-387 study results: Venclexta + azacitidine & decitabine: CR (37%, 54%); CRh (24%, 8%); median observed time in remission (5.5 mos, 4.7 mos.); median follow up (7.9 mos., 11mos.); Venclexta + LDAC; CR 21%, CRh 21%, median follow up 6.5mos., median observed time in remission 6.0 mos.
• Venclexta is an inhibitor of B-cell lymphoma-2 (BCL-2) protein, while supporting apoptosis and has also received FDA’s four BT designation in combination with Rituxan for r/r CLL. Venclexta is jointly developed by AbbVie & Roche

Click here to read full press release/ article | Ref: AbbVie | Image: The San Diego Union-Tribune