The FDA approved Servier Pharmaceuticals drug Voranigo as a treatment for two types of brain cancer. The brain-penetrating small molecule is the first FDA-approved systemic therapy for Grade 2 astrocytoma or oligodendroglioma driven by mutations to IDH1 or IDH2 enzymes. The Servier drug is designed to inhibit these mutated enzymes. Servier and Thermo Fisher Scientific are developing a companion diagnostic to identify patients eligible for treatment with Voranigo. The drug, a key piece of Servier’s 2021 acquisition of the oncology business of Agios Pharmaceuticals, is projected to become a blockbuster seller.

The Moolah: Servier paid $1.8 billion to buy Agios’s cancer business. With Voranigo’s approval, Servier now owes Agios a $200 million milestone payment.

Why it Matters: Surgery is the first treatment option for patients with Grade 2 astrocytoma or oligodendroglioma. But if these brain cancers progress to high-grade gliomas, the next treatment options are radiation or chemotherapies, which introduce a wide range of adverse effects. As a once-daily pill, Voranigo offers patients a less burdensome alternative treatment with a manageable safety and tolerability profile.

The Unanswered Question: Servier said Voranigo is available now. But for patients to get it, their cancers need confirmation of the IDH1 or IDH2 mutations. When will the companion diagnostic become available?

Soundbite: “As we advance more targeted therapies, identifying mutations and understanding how these mutations impact cancer and its progression are key to helping the right patients find the right treatment, at the right time,” Servier CEO David Lee said. “We are humbled to lead the field of IDH-mutant inhibition, and we are committed to researching its applicability in glioma and other cancers.”