Onco-Summaries: Daily Oncology Updates at a Glance

26/01/2026

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• Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST

  
  

• Innovent Biologics' IBI3003 received the FDA Fast Track Designation for multiple myeloma

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Cogent Biosciences' bezuclastinib + sunitinib received the FDA Breakthrough Therapy Designation for GIST (Ref) 

The US FDA granted the Breakthrough Therapy Designation to Cogent Biosciences' bezuclastinib (tyrosine kinase inhibitor) in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib.

• Andrew Robbins, President and Chief Executive Officer, Cogent: “We are excited to announce this Breakthrough Therapy Designation which recognizes the potential for the bezuclastinib combination to substantially improve upon the currently available treatment options for patients with imatinib-resistant GIST. We look forward to the continued collaboration with the FDA as we work to bring the first new treatment option in over twenty years to this patient population.”

• Previously, the FDA agreed to accept Cogent’s NDA under the FDA’s Real-Time Oncology Review (RTOR) program

Innovent Biologics' IBI3003 received the FDA Fast Track Designation for multiple myeloma (Ref)

The US FDA granted the Fast Track Designation to Innovent Biologics' IBI3003 (anti-GPRC5D/BCMA/CD3 tri-specific antibody) for the treatment of relapsed or refractory multiple myeloma patients who have received four or more lines of previous anti-myeloma therapies, that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.

• Dr. Hui Zhou, Chief R&D Officer of Oncology, Innovent: "IBI3003 monotherapy has demonstrated encouraging efficacy and a favorable safety profile in R/R MM patients who had received three or more prior lines of therapy. Notably, meaningful clinical activity was observed even in high-risk patients with EMD or those previously treated with anti-BCMA and/or GPRC5D-targeted therapies, highlighting IBI3003's potential to address key unmet needs. Its overall manageable safety profile further supports continued investigation and the potential for durable survival benefit. The Fast Track Designation granted by the U.S. FDA represents an important milestone in the global development of IBI3003, and we look forward to further evaluating its potential to benefit patients worldwide."