AbbVie Announces US FDA Approval of VENCLEXTA« (venetoclax) as a Chemotherapy-Free Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia Patients

Thursday, May 16, 2019 General News
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- FDA reviewed the submission under the Real-Time Oncology Review pilot program

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VENCLEXTA (venetoclax) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

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American Cancer Society (2018). Chronic Lymphocytic Leukemia (CLL). https://www.cancer.org/cancer/chronic-lymphocytic-leukemia.html. Accessed January 2019.

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Clinicaltrials.gov (2018). NCT02242942: A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax (GDC-0199/ABT-199) Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions. Accessed February 2019.

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Clinicaltrials.gov (2018). NCT02993523: A study of venetoclax in combination with azacytidine versus azacytidine in treatment na´ve subjects with acute myeloid leukemia who are ineligible for standard induction therapy. Accessed January 2019.

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Clinicaltrials.gov (2018). NCT03069352: A study of venetoclax in combination with low dose cytarabine versus low dose cytarabine alone in treatment na´ve patients with acute myeloid leukemia who are ineligible for intensive chemotherapy. Accessed January 2019.

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Clinicaltrials.gov (2018). NCT01794520: Study evaluating ABT-199 in subjects with relapsed or refractory Multiple Myeloma. Accessed January 2019.

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Clinicaltrials.gov (2018). NCT01328626: A Phase 1 study evaluating the safety and pharmacokinetics of ABT-199 in subjects with relapsed or refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma. Accessed January 2019.

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Clinicaltrials.gov (2018). NCT02942290: A study evaluating venetoclax in combination with azacytidine in subjects with treatment-na´ve higher-risk myelodysplastic syndromes (MDS). Accessed January 2019.

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U.S. Food and Drug Administration (2016). News and Events: FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-chronic-lymphocytic-leukemia-patients-specific-chromosomal-abnormality. Accessed January 2019.

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U.S. Food and Drug Administration (2018). Approved Drugs: FDA approves venetoclax in combination for AML in adults. https://www.fda.gov/drugs/fda-approves-venetoclax-combination-aml-adults. Accessed January 2019.



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