Vivek Subbiah, Professor at Stanford University, shared on LinkedIn:
“Another big win for Precision Medicine.
Today the FDA approved lirafugratinib for FGFR2‑rearranged cholangiocarcinoma.
I still remember the first patient in the universe we enrolled on the trial during the peak of the pandemic.
Three days in – I called the amazing drug developer Beni Wolf – the then CMO of Relay Therapeutics.
‘The drug is working, working too good. We need to work on the right dosing and get it right for patients. I think this baby will graduate someday.’ That day is today.
Thankful to all patients who volunteered and the amazing teams at Elevar Therapeutics
that got this to finish line!
Link to FDA approval.
Link to American Association for Cancer Research flagship AACR Journals Cancer Discovery first disclosure, clinical proof and bench to bedside publication.”
Title: RLY-4008, the First Highly Selective FGFR2 Inhibitor with Activity across FGFR2 Alterations and Resistance Mutations
Authors: Vivek Subbiah, Vaibhav Sahai, Dejan Maglic, Kamil Bruderek, B. Barry Touré, Songping Zhao, Roberto Valverde, Patrick J. O’Hearn, Demetri T. Moustakas, Heike Schönherr, Nastaran Gerami-Moayed, Alexander M. Taylor, Brandi M. Hudson, Damian J. Houde, Debjani Pal, Lindsey Foster, Hakan Gunaydin, Pelin Ayaz, Dina A. Sharon, Lipika Goyal, Alison M. Schram, Suneel Kamath, Cori Ann Sherwin, Oleg Schmidt-Kittler, Kai Yu Jen, Fabien Ricard, Beni B. Wolf, David E. Shaw, Donald A. Bergstrom, James Watters, Jessica B. Casaletto
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