Voranigo Receives FDA Clearance as a Brain Tumor Inhibitor

Servier has enriched its portfolio of IDH-targeted drugs for next year thanks to FDA approval of a dual IDH1/2 inhibitor. The approval signifies a breakthrough in the treatment of low-grade brain cancer, as it has been more than twenty years since a significant advancement in the treatment of the disease was achieved.

The most recent approval from the FDA is for Servier’s Voranigo, or Vorasidenib, for adults with low-grade glioma with susceptible IDH1 or IDH2 mutation and children aged 12 years and above. As the FDA mentions in its press release, it is the first time it has approved a systemic therapy for this kind of grade 2 IDH-mutant brain cancer, which includes oligodendrogliomas and astrocytomas.

Voranigo became part of Servier when the latter purchased the oncology division of Agios Pharmaceuticals in 2021 in a $2 billion deal. Following a similar process, Royalty Pharma, which invested earlier in 2014 for a certain percentage of Agios’ royalty rights for Voranigo, has estimated that the drug could generate over $1 billion in annual peak revenue in the U.S.

Gliomas are the most prevalent malignant brain tumors in adults, and IDH1 and IDH2 mutations are identified in virtually all adult grade 2 DGs. Using available data, Royalty presumes that there are about 1,500 newly diagnosed patients with these two IDH-mutated gliomas in the U.S. annually.

Servier has other drugs, such as the IDH1 inhibitor Tibsovo and the IDH2 inhibitor Idhifa, which were available before the acquisition of Voranigo. While the two medications have been prescribed by doctors for this purpose due to inadequate treatment options, neither of the two were registered for brain cancer.

In the phase 3 trial called INDIGO, Voranigo lowered the probability of tumor progression or death by 61% compared to a placebo for patients with a residual or recurrent grade 2 glioma that was IDH-mutant. These patients had received no prior care except surgery.

Additionally, Voranigo demonstrated a significant improvement in the time to the next treatment, reducing the risk of subsequent treatment by 74% in the trial based on statistical data.

The trial is still open to get more overall survival data for the patients. However, rationalizing his claims, Hassan added that the PFS data are equally significant since these tumors will keep on progressing and infiltrating the brain and may turn into a high-grade form.

Apart from the Voranigo monotherapy regimen, Servier is active in the Phase Ib/II trial of the IDH inhibitor combined with Merck’s anti-PD-1 immunotherapy Keytruda in recurrent or progressive IDH1-mutant glioma.

Although anti-PD-1 antibodies such as Keytruda have not shown good outcomes in brain tumors, Hassan found a prior study where patients were administered Voranigo along with Keytruda before surgery. Looking at actual tissues taken from the patients during surgery, Servier observed certain changes in the immune microenvironment that, according to Hassan, should contribute to further work on this combination.

Servier is also documenting Voranigo with temozolomide chemotherapy in high-grade IDH-mutant glioma. The FDA approval leads to a $200 million payment from Servier to Agios. Furthermore, Royalty pays $905 million to Agios in exchange for a 15% royalty on up to $1 billion of the therapy’s U.S. net sales.

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