FDA grants BTD for Venclexta in combination with azacitidine to treat patients with myelodysplastic syndromes

Every year, approximately 10,000 people are diagnosed with myelodysplastic syndromes (MDS) in the US, and there remains a high unmet need for new treatment options

Roche has announced that Venclexta (venetoclax), in combination with azacitidine, has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International Prognostic Scoring System (IPSS-R).

In a statement, the company said that this designation was granted based on interim results from the phase Ib M15-531 study investigating Venclexta/Venclyxto plus azacitidine in people with previously untreated, higher-risk MDS.

BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies. This is the 38th BTD for Roche’s portfolio of medicines, and the 11th designation for its haematology portfolio, it further mentioned.

Levi Garraway, MD, PhD and Chief Medical Officer and Head of Global Product Development, Roche, said, “Higher-risk MDS is associated with poor prognosis, reduced quality of life, and limited treatment options.”

He added, “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.”

According to the statement, MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells. This can lead to weakness, frequent infections, anaemia and debilitating fatigue. In some cases, MDS can also progress into acute myeloid leukaemia (AML). Every year in the US, approximately 10,000 people are diagnosed with MDS, and the median survival for those with higher-risk MDS is approximately 18 months.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, under the brand name Venclexta, and commercialised by AbbVie outside of the US, the statement further stated.

AbbVieazacitidineBreakthrough Therapy DesignationGenentechRocheVenclextaVenclyxto
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