Venclexta + azacitidine receive breakthrough therapy designation from FDA for myelodysplastic syndromes

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

Venclexta (venetoclax) in combination with azacitidine was granted Breakthrough Therapy Designation from FDA for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes based on the revised International Prognostic Scoring System. 

This designation was granted based on interim results from the phase Ib M15-531 study investigating Venclexta plus azacitidine in people with previously untreated, higher-risk MDS.

This is the 38th BTD for Genentech’s portfolio of medicines, and the 11th designation for its hematology portfolio.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group.

Table of Contents

YOU MAY BE INTERESTED IN

By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it.  To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...

As a radiation oncologist, I am struck by how often the decisive variable in lung cancer is not the sophistication of our therapy, but the timing of our encounter with the disease.  The American Cancer Society projects 618,120 cancer deaths in the United States in 2025, with lung cancer remaining as the single largest contributor,...

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login