Nuvation Bio announced the successful completion of 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). 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 Chief Executive Officer 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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