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2020-10-19| Trials & Approvals

FDA Approves Venetoclax Combination for New Acute Myeloid Leukemia Cases

by Tulip Chakraborty
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By T. Chakraborty, Ph.D.

Although Acute Myeloid Leukemia (AML) is one of the most common types of leukemia in adults, it only accounts for 1% of all cancers. AML generally affects the older population and is uncommon before the age of 45. However, rare cases might be present in children as well. The American Cancer Society estimates that in the US alone, it is expected that about 19,940 new cases of AML will arise in adults with approximately 11,180 deaths for the year 2020 [1]. Treatment options for this disease include chemotherapy, combination drugs, and blood transfusion, impacting a patient’s quality of life.

On October 16th, the US Food and Drug Administration (FDA) granted full approval of Venetoclax (Venclexta) to treat newly diagnosed AML. The approval granted to Genentech needs to be used in amalgamation with azacitidine, decitabine, or low dose cytarabine, for adults who are 75 years or older and might have comorbidities that would inhibit the use of intensive induction chemotherapy [2].

Levi Garraway, M.D., Ph.D., Chief Medical Officer and head of Global Product Development of Genentech commented, “ Today’s full approval is supported by the significant results that showed that Venclexta in combination with azacitidine extended overall survival for people with newly diagnosed acute myeloid leukemia who cannot tolerate intensive induction chemotherapy. We are very pleased that this application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this treatment option more rapidly to patients in the United States and other countries” [2].

 

Venetoclax

Venetoclax is a first-in-class drug that inhibits the B-cell lymphoma-2 (BCL-2) protein, which is dysregulated in multiple cancer types, including leukemia. This drug was developed as a collaboration between AbbVie and Roche and commercialized by Genentech and Abbvie. This is the second BCL-2 inhibitor from AbbVie after Navitoclax. Venetoclax was granted accelerated approval in November 2018 and bagged priority review, breakthrough designation, and orphan drug designations by the FDA previously.

 

VIALE-A and VIALE-C Trials

VIALE-A is a Phase III randomized double-blinded clinical trial that tested the efficacy and safety of combination therapy of Venetoclax plus azacitidine over azacitidine alone. A total of 431 patients were enrolled in this study. The overall survival was 14.7 months in patients treated with combination therapy compared to 9.6 in patients treated with azacitidine alone. Further, 37% of patients in the combination therapy group attained complete remission compared to only 18% in the control group [2].

VIALE-C is a Phase III randomized double-blinded clinical trial that tested the efficacy and safety of combination therapy of Venetoclax plus LDAC over LDAC alone. A total of 211 patients were enrolled in this study. The overall survival was not statistically significant in patients treated with combination therapy compared to patients treated with LDAC alone. However, 27% of the combination therapy group attained complete remission compared to only 7.4% in the control group [2]. The most common adverse reactions with the drug were nausea, diarrhea, and constipation.

Related Article: Bristol Myers Squibb Notches Key Regulatory Win for Oral Formulation of Epigenetic Modifier

References
  1. https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html
  2. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-regular-approval-venetoclax-combination-untreated-acute-myeloid-leukemia

 

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