AbbVie Announces U.S. FDA Approval of VENCLEXTAŽ (venetoclax tablets) in Combination with Rituximab as a Fixed Duration Treatment for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients Who Have Received One Prior Therapy

Saturday, June 9, 2018 Cancer News
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-- In the MURANO Phase 3 clinical trial, the VENCLEXTAŽ (venetoclax tablets) plus rituximab combination showed a significant improvement in progression-free survival (PFS) for relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) patients, reducing the risk of disease progression or death by 81 percent when compared to a standard of care chemoimmunotherapy regimen, bendamustine plus rituximab (1)

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

2 Farrell A. Grant-Breakthrough Therapy Designation (CLL). Department of Health and Human Services. 2016:1-3.

3 American Cancer Society (2015). Chronic Lymphocytic Leukemia (CLL).

 http://www.cancer.org/acs/groups/cid/documents/webcontent/003111-pdf.pdf. Accessed June 2018.

4 Seattle Cancer Care Alliance (2018). Chronic Lymphocytic Leukemia Facts. https://www.seattlecca.org/diseases/chronic-lymphocytic-leukemia-cll/cll-facts. Accessed June 2018.

5 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/NewsEvents/Newsroom/PressAnnouncements/ucm495253.htm. Accessed June 2018.

6 Clinicaltrials.gov (2018). NCT01994837: A Phase 2 Study of ABT-199 in subjects with Acute Myelogenous Leukemia (AML). Accessed June 2018.

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

8 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 June 2018.

9 Clinicaltrials.gov (2018). NCT01889186: A study of the efficacy of ABT-199 in subjects with relapsed/refractory or previously untreated chronic lymphocytic leukemia with the 17p deletion. Accessed June 2018.

10 U.S. Food and Drug Administration (2018). Fact Sheet: Breakthrough Therapies. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.html. Accessed June 2018.



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