Genentech’s Venclexta (venetoclax) + Azacitidine Receives Breakthrough Therapy Designation for the Treatment of Myelodysplastic Syndromes

July 21, 2021 Auto Bot regulatory 0

Shots:

  • The designation is based on interim results from the P-Ib M15-531 study evaluating Venclexta + azacitidine in naïve patients with previously untreated higher-risk MDS
  • The primary objectives of the study are to assess the safety, Pk and determine the RP2D and dosing schedule of Venclexta in combination with azacitidin
  • Venclexta is a novel inhibitor of BCL-2 protein, jointly developed & commercialized by Genentech & Abbvie in the US & commercialized by AbbVie outside of the US. The therapy is also approved in the US & EU in combination with Rituxan for the treatment of CLL & in combination with Gazyva for the treatment of patients with previously untreated CL

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