Servier gains FDA nod for glioma drug from Agios deal

The U.S. Food and Drug Administration (FDA) has granted approval to Servier Pharmaceuticals for its new drug, Voranigo (vorasidenib), aimed at treating specific brain tumors. Voranigo targets individuals aged 12 and older who have Grade 2 astrocytoma or oligodendroglioma, provided these tumors have a susceptible IDH1 or IDH2 mutation. This approval follows various types of surgery, including biopsy, sub-total resection, or gross total resection. This milestone makes Voranigo the first systemic therapy approved for this specific medical condition.

Servier Pharmaceuticals acquired Voranigo as part of its purchase of Agios Pharmaceuticals' oncology division in a deal valued at $1.8 billion back in 2021. The approval comes on the heels of compelling data presented by Servier at the American Society of Clinical Oncology (ASCO) annual meeting in 2023. The key study that drove this approval is the Phase III INDIGO trial, which involved 331 patients who had Grade 2 IDH-mutated gliomas and had undergone surgical procedures.

In the INDIGO study, participants were randomized to receive either a daily 40-milligram dose of Voranigo or a placebo. The findings showed that patients treated with Voranigo experienced a median radiographic progression-free survival of 27.7 months. In comparison, the placebo group had a median progression-free survival of just 11.1 months. 

Regarding secondary endpoints, the median time to the next treatment for patients in the placebo group was 17.8 months. However, this measurement was not reached among those treated with Voranigo, suggesting a prolonged benefit from the drug.

In terms of safety, the most frequently reported adverse events among patients treated with Voranigo were relatively mild. These included fatigue, headache, musculoskeletal pain, diarrhea, and nausea. However, there were some more severe side effects as well. Grade 3 or higher adverse events observed in more than 2% of patients included elevated levels of liver enzymes ALT and AST, as well as a decrease in neutrophil counts.

The approval of Voranigo marks a significant advancement in the treatment of brain tumors with IDH1 and IDH2 mutations. The drug offers a new therapeutic option for individuals who have undergone surgical procedures for their tumors, potentially improving their progression-free survival and extending the time before additional treatments are needed. This development underscores Servier Pharmaceuticals' commitment to advancing cancer treatment and providing new hope for patients affected by these challenging conditions.

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