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FDA Approval Sought for Venetoclax/Obinutuzumab Combo for Frontline CLL

Gina Columbus @ginacolumbusonc
Published: Thursday, Mar 07, 2019

Dr. Sandra Horning

Sandra Horning, MD
A supplemental new drug application (sNDA) has been filed for the combination of venetoclax (Venclexta) and obinutuzumab (Gazyva) for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) who also have coexisting medical conditions.1

 

References

  1. Genentech Submits Supplemental New Drug Application to FDA for Venclexta Plus Gazyva for Previously Untreated Chronic Lymphocytic Leukemia with Co-Existing Medical Conditions. Genentech (Roche). Published March 7, 2019. https://bit.ly/2C9as21. Accessed March 7, 2019.
  2. Fischer K, Fink A-M, Bishop H, et al. Results of the safety run-in phase of CLL14 (BO25323): a prospective, open-label, multicenter randomized phase iii trial to compare the efficacy and safety of obinutuzumab and venetoclax (GDC-0199/ABT-199) with obinutuzumab and chlorambucil in patients with previously untreated CLL and coexisting medical conditions. Presented at: 2015 ASH Annual Meeting; December 5-8, 2015; Orlando, FL. Abstract 496.
  3. Fischer K, Al-Sawaf O, Fink AM, et al. Venetoclax and obinutuzumab in chronic lymphocytic leukemia. Blood. 2017;129(19):2702-2705. doi: 10.1182/blood-2017-01-761973.

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