News Related to Sunitinib

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FDA grants Breakthrough Therapy Designation to bezuclastinib plus sunitinib in GIST

May 05, 2026

The FDA granted Breakthrough Therapy Designation to bezuclastinib plus sunitinib for previously treated GIST. The PEAK trial showed median progression-free survival of 16.5 months versus 9.2 months for sunitinib alone.

Cogent Biosciences Prepares Up to Three FDA Filings for Bezuclastinib Following Pivotal Wins

Mar 15, 2026

Cogent Biosciences is preparing parallel FDA submissions for bezuclastinib across three indications following positive pivotal trial results, with potential launches beginning in late 2026 and full commercialization expected by early 2027.