- The Phase 3 CLL14 trial of venetoclax in combination with obinutuzumab is the first randomized clinical trial to examine a chemotherapy-free treatment given for a fixed duration in previously-untreated patients with chronic lymphocytic leukemia (CLL) and comorbidities
- Submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) is complete for the venetoclax and obinutuzumab combination for previously-untreated CLL patients
- FDA will review the application under the Real-Time Oncology Review (RTOR) pilot program, signaling the Agency's intention to expedite the review
- FDA has also granted venetoclax a fifth Breakthrough Therapy Designation (BTD) based on the Phase 3 CLL14 clinical trial
PR Newswire
NORTH CHICAGO, Ill., March 7, 2019
