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# Genentech sNDA Submitted for Venclexta for Leukemia
- URL: https://www.fdaweb.com/genentech-snda-submitted-for-venclexta-for-leukemia/
- Published: 2019-03-07T12:00:00.000Z
- Updated: 2026-09-15T01:10:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143551

Genentech has submitted a supplemental NDA for Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. FDA is reviewing the application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to expedite treatments, the company says.

A breakthrough therapy designation was granted based on results of the randomized Phase 3 CLL14 study, evaluating the fixed-duration combination of Venclexta plus Gazyva, compared to Gazyva plus chlorambucil, in people with previously untreated CLL and co-existing medical conditions. The study, according to the company, met its primary endpoint and showed a statistically significant reduction in disease risk worsening or death (progression-free survival) compared to standard-of-care Gazyva plus chlorambucil.

Venclexta is being developed by AbbVie and Genentech. It is jointly being commercialized in the U.S. and commercialized by AbbVie elsewhere.