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Nuvation Bio Completes IBTROZI Manufacturing Tech Transfer to Thermo Fisher

The completed transfer supports U.S. final drug product manufacturing for IBTROZI.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Nuvation Bio Inc., a global oncology company, has completed a process tech transfer and product introduction to Thermo Fisher Scientific for IBTROZI (taletrectinib) to treat advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).

IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. The transition was submitted as a supplement to the IBTROZI New Drug Application held by Nuvation Bio and is now complete.

“Our commitment to unencumbered access to IBTROZI for appropriate patients with ROS1+ NSCLC starts at the manufacturing stage, where we work to ensure that our collaborators and processes deliver critical medicine with high quality,” said David Hung, M.D., Founder, President and CEO of Nuvation Bio. “We are pleased to collaborate with Thermo Fisher, a leading contract manufacturer of pharmaceuticals, to bring IBTROZI manufacturing closer to the patients we serve.”

Jennifer Cannon, President, Commercial Operations, Pharma Services at Thermo Fisher added, “We are pleased that Nuvation Bio has selected us for their final drug product manufacturing of IBTROZI in the United States. Our collaboration with Nuvation Bio builds on our commitment to work with both biotech and pharmaceutical companies alike to help ensure the availability and access to innovative treatments that address significant unmet medical needs for patients.”

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