Celgene is squeezing the trigger on an early FDA filing for key Agios cancer drug
Six years after Celgene helped get the R&D ball rolling at Agios with a worldwide pact that covered the global rights for its promising AG-221, the big biotech is teeing up a straight shot at an accelerated approval for acute myeloid leukemia based after planning an early look at efficacy data.
In an SEC filing out this morning, Agios reports that later today Celgene will review a plan to file for an early approval on AML before the end of this year. And Agios itself is prepping a plan to hustle an NDA to the FDA next year for a quick OK on AG-120, a closely related IDH1 mutation therapy which Celgene recently handed back in a deal to rework their longstanding collaboration.
The news spurred a 20% spike in Agios’ share price on Wednesday.
According to an 8-K, Agios reports that:
“The (Celgene) NDA will be based on data from the ongoing phase 1/2 study of AG-221 in patients with advanced hematologic malignancies with an IDH2 mutation. The NDA submission is expected to occur by year-end 2016. Celgene will be discussing the planned enasidenib NDA submission at the Citi 11th Annual Biotech Conference in Boston in a webcast event on Wednesday, September 7, 2016 at 12:00 pm ET.”
Celgene was drawn to the partnership by Agios’ focus on drugs that inhibit an enzyme needed to metabolize nutrients. IDH1 and IDH2 are mutated in cancer, driving proliferation of the cancer.
Back in the spring, Celgene handed back its ex-US rights to AG-120, which has performed well for hematological malignancies but not so well in solid tumors. But the big biotech also handed over $200 million up front to add to its package of molecules while carrying on with AG-221.
In March, Celgene and Agios set out to enroll 150 AML patients with a plan to treat them with a combination of either AG-221 or AG-120 with Vidaza or Vidaza alone. Celgene holds the worldwide rights to AG-221, while Agios is still in line for a rich set of milestones for their development program.
The move at Celgene to shift their focus to a potential approval at this stage marks a key turning point for a biotech which Agios CEO David Schenkein is fond of recalling started out with little more than a blank sheet of paper. Since then, the pages at Agios have been filled with high-profile partnerships an IPO for its potential cutting-edge work and mixed progress in the clinic.