Part 2. Accelerated Development of a New Commercial Process and CMC Control Strategy for ABT-199<br/><br/>Venetoclax (ABT-199) has obtained regulatory approval for patients with previously treated chronic lymphocytic leukemia (CLL) who harbor a 17P deletion. Phase I and II clinical studies demonstrated promising results leading to an accelerated approval in CLL, and clinical trials are ongoing in several other hematological cancer indications. This presentation describes the development of an efficient and robust manufacture process and its control strategies under an accelerated timeline. The new process involves several new innovative approaches and it successfully addresses the technical challenges and process control concerns associated with the early large scale enabling process.

Synthetic routes to Venetoclax at different stages: From discovery to early development to commercialization (part 2)

256th National Meeting (2018)

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