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

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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

Ref: AbbVie | Image: The San Diego Union-Tribune


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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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