Fifth BTD for AbbVie and Genentech Drug


AbbVie, a research-based global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) granted a fifth Breakthrough Therapy Designation (BTD) to venetoclax, for use in combination with obinutuzumab as a fixed duration investigational combination, for untreated adult patients with chronic lymphocytic leukemia (CLL). According to the FDA, this designation is intended to expedite the review of therapies for serious or life-threatening conditions. The designation coincides with the completion of the supplemental New Drug Application (sNDA) submission to the FDA for approval in previously-untreated CLL patients.

The FDA will review the venetoclax and obinutuzumab combination under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective cancer medicines are available to patients as early as possible.

We studied the venetoclax and obinutuzumab combination with a fixed treatment duration and found these medicines, used together, may enable some CLL patients to live longer without their disease getting worse, leading to longer progression-free survival, while remaining off therapy. Under the RTOR program, we are determined to work with the FDA and bring this first- and only-in-class medicine to previously-untreated CLL patients earlier than expected,

said Mohamed Zaki,
M.D., Ph.D., vice president,
global head of hematology development, AbbVie.

The sNDA for the venetoclax and obinutuzumab combination is based on data from the Phase 3 CLL14 trial, which studied patients receiving the combination treatment for 12 months as their first treatment for CLL. CLL14 is the first randomized trial in CLL to examine a chemotherapy-free, fixed duration treatment regimen.

The FDA’s standard review time for drug applications is six to 10 months. The RTOR program focuses on the early submission of data most relevant to assessing the product’s safety and effectiveness. RTOR allows the FDA to review much of the data before it is formally submitted to the FDA.

VENCLEXTA® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.