Evicenter
P&T meetings

Bezuclastinib

Gastrointestinal stromal tumor

Manufacturer
Cogent Biosciences
Regulatory submission
NDA submitted April 2026
Last updated
76 sources

Product information and disease descriptionProduct description

Phase of product development

7 evidence topics · 8 sources

Orphan designation and regulatory status

“Date Designated: 07/21/2021” (opens the source at this quote in a new tab)

“Not FDA Approved for Orphan Indication” (opens the source at this quote in a new tab)

Special FDA designations

“has granted Breakthrough Therapy Designation (BTD) for bezuclastinib in combination with sunitinib” (opens the source at this quote in a new tab)

Regulatory submission: NDA submitted April 2026

“April 1, 2026” (opens the source at this quote in a new tab)

“Bezuclastinib NDA submitted under the FDA’s RTOR program” (opens the source at this quote in a new tab)

“today announced the completion of the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST)” (opens the source at this quote in a new tab)

Priority review and advisory committee

“has granted the application Priority Review” (opens the source at this quote in a new tab)

“there is no plan to hold an advisory committee” (opens the source at this quote in a new tab)

Anticipated FDA approval date

“Potential FDA approval of bezuclastinib in GIST” (opens the source at this quote in a new tab)

“PDUFA date of November 30, 2026” (opens the source at this quote in a new tab)

Launch: Anticipated in the second half of 2026

“pending regulatory approval, the company expects to launch bezuclastinib commercially in the United States in the second half of 2026.” (opens the source at this quote in a new tab)

“Pending FDA approval(s), launch bezuclastinib in the second half of 2026” (opens the source at this quote in a new tab)

“the NDA for GIST is also under FDA review, with a PDUFA target action date of November 30, 2026” (opens the source at this quote in a new tab)

“ready for the potential launches later this year” (opens the source at this quote in a new tab)

PEAK extension: first-line KIT exon 9-mutant GIST

“a single-arm, 40 patient extension cohort of the PEAK trial” (opens the source at this quote in a new tab)

“first-line GIST patients with KIT exon 9 primary mutations” (opens the source at this quote in a new tab)