Active ingredient: ivosidenib
Disease: relapsed or refractory acute myeloid leukemia patients with the IDH1 mutation
Peak sales estimate: $300 million
Approved: July 20, 2018
Company: Agios Pharmaceuticals
The scoop: Agios’ first solo approved effort, after the FDA green light for its Celgene-partnered blood cancer drug Idhifa, Tibsovo is now on the market for relapsed or refractory acute myeloid leukemia (AML) patients with the IDH1 mutation. It won’t be a blockbuster, with peak sales hovering around the $300 million mark, but it’s still on the hook to treat around 700 to 1,100 patients with the mutation in the U.S.
Combined with IDH2 inhibitor Idhifa, Agios drugs cover about 20% of the AML patient population; but next-gen CAR-T therapies from the likes of Celyad in AML patients, and more broadly across blood cancers from Celgene, Novartis and Gilead, could become more attractive to patients in the future.
But for payers, Agios will beat them out on price: It’s charging $26,115 per month, whereas the latest CAR-T therapies are going for around $400,000 to $500,000 (although discounts may be coming).
Tibsovo does come with a black-box warning, specifically detailing risks of differentiation syndrome, but analysts at SunTrust said this is “unlikely” to be a barrier to uptake. — Ben Adams