FDA grants breakthrough therapy designation to venetoclax for myelodysplastic syndrome
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The FDA granted breakthrough therapy designation to venetoclax in combination with azacitidine for treatment of certain patients with myelodysplastic syndrome.
The designation applies to adults with previously untreated intermediate-, high- and very high-risk myelodysplastic syndrome (MDS) based on the revised International Prognostic Scoring System.
Venetoclax (Venclexta; AbbVie, Genentech), a BCL-2 inhibitor, is approved in the United States for treatment of certain patients with acute myeloid leukemia, chronic lymphocytic leukemia or small lymphocytic lymphoma.
The FDA based the breakthrough therapy designation on interim results of the phase 1B M15-531 study, designed to evaluate venetoclax plus azacitidine for people with untreated higher-risk MDS.
Approximately 10,000 people in the United States are diagnosed with MDS each year. Median survival for patients with higher-risk disease is about 18 months.
“Higher-risk MDS is associated with poor prognosis, reduced quality of life and limited treatment options,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in a company-issued press release. “We are pleased that the FDA has granted Venclexta its sixth breakthrough therapy designation in recognition of its potential to improve outcomes for people with MDS in combination with azacitidine.”
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