Genentech, the California-based biotechnology firm, has announced that the U.S. Food and Drug Administration has greenlit the classification of its Venclexta (venetoclax) and azicitidine combination as a Breakthrough Therapy Drug (BTD). The drug is designed to treat adults who had not received any form of therapy for intermediate, high- and very high-risk myelodysplastic syndromes (MDS), as defined by the International Prognostic Scoring System (IPSS-R).

According to a press release, the BTD designation was granted based on positive partial results from its Phase Ib M15-531 trial on patients with higher-risk MDS. A BTD is designed to accelerate the development and evaluation of new medicines to support treatment creation efforts for serious or life-threatening illnesses, specifically those that showed a higher efficacy over the currently being used drugs. This is Genentech’s 38th BTD for its medicine portfolio and 11th BTD for hematology.

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