AbbVie - Roche's Venclexta Receives Breakthrough Therapy Tag In High-Risk Myelodysplastic Syndromes

AbbVie - Roche's Venclexta Receives Breakthrough Therapy Tag In High-Risk Myelodysplastic Syndromes

The FDA has granted Breakthrough Therapy Designation (BTD) to Venclexta (venetoclax) combined with azacitidine for the potential treatment of adult patients with myelodysplastic syndromes (MDS).

  • Venclexta is being developed by AbbVie Inc ABBV and Roche Holdings AG RHHBY
  • The Breakthrough status is intended to expedite the development and review of medications. It is granted when preliminary clinical evidence indicates the investigational therapy may demonstrate substantial improvement over existing therapies.
  • It marks the sixth BTD granted to venetoclax.
  • Venclexta/Venclyxto (venetoclax) selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. 
  • Price Action: ABBV and RHHBY shares closed at $116.05 and 48.08, respectively, on Tuesday.
  • Related content: Benzinga's Full FDA Calendar.

Posted In: BriefsFDA Breakthrough Designationmyelodysplastic SyndormesBiotechNewsHealth CareFDAGeneral