Monday, July 15, 2024

FDA Approves Servier’s Tibsovo as First IDH Inhibitor for Myelodysplastic Syndromes

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Servier has achieved a milestone as it secures FDA approval for Tibsovo (ivosidenib), making it the first-ever IDH inhibitor authorized for treating myelodysplastic syndromes (MDS). This development marks a significant advancement in the treatment of rare blood cancers.

Tibsovo, already recognized for its effectiveness in IDH1-mutant acute myeloid leukemia (AML) and cholangiocarcinoma, has now gained clearance for treating patients with IDH1-mutated relapsed or refractory MDS.

Richard Pazdur, Head of the FDA’s Center for Drug Evaluation and Research, highlighted the importance of this achievement, noting that Tibsovo represents the first targeted therapy for this specific cancer type. He referred to it as a crucial step forward in addressing rare blood cancers.

In tandem with this approval, the FDA has also sanctioned the use of the Abbott RealTime IDH1 Assay, a companion diagnostic tool designed to identify MDS patients eligible for Tibsovo treatment. Approximately 60,000 to 170,000 individuals in the United States are affected by MDS, with approximately 3.6% of them having an IDH1 mutation.

Servier gained possession of the IDH1 inhibitor through its acquisition of Agios Pharma’s oncology division in 2021, a move that has significantly contributed to the French pharmaceutical company’s sales growth. In the 2021/2022 fiscal year, Tibsovo generated €256 million ($280 million), marking a 180% increase in sales.

Oncology plays a central role in Servier’s growth strategy, accounting for more than 17% of its total revenues, which exceeded €848 million in the previous fiscal year. With FDA approval in the MDS category, Tibsovo now enjoys a niche without competition from other IDH inhibitors like Bristol Myers Squibb’s Idhifa (enasidenib) and Rigel’s Rezlidhia (olutasidenib), both of which are approved for AML treatment.

Arjun Prasad, Head of Commercial at Servier, emphasized that this approval underscores their commitment to addressing unmet medical needs and delivering timely, tailored treatments to patients.

Myelodysplastic syndromes encompass a heterogeneous group of hematopoietic stem cell disorders, with a notable propensity to evolve into AML. Each year in the United States, approximately 16,000 new MDS cases are reported, as estimated by the National Cancer Institute (NCI). IDH1 mutations elevate the risk of progression to AML.

The FDA’s approval for Tibsovo in the MDS category is grounded in data from a subset of 18 patients participating in a pivotal phase 1 trial. The results, presented at the European Hematology Association (EHA) meeting in June, demonstrated an impressive overall response rate of 83%, with nearly 40% achieving a complete response. The median time to a complete response was 1.87 months, and the median overall survival at that point approached three years.

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