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

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  • 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 has 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

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Kronos Bio raises $155M in private financing to advance lead leukemia drug into registration study next year

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The company has raised $148 million so far and plans to raise the remaining $7 million by next month. Its lead candidate is entospletinib, a SYK inhibitor acquired as part of a deal with Gilead Sciences last month, under development for patients with biomarker-defined acute myeloid leukemia.