.png)
Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Apr 2
- 2 min read
Updated: Apr 3
01/04/2026
Cogent completed the NDA submission for bezuclastinib in GIST (Ref)
Cogent Biosciences completed the NDA submission to the US FDA for bezuclastinib (KIT inhibitor) in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib.
The filing was based on the positive results from the Phase 3 PEAK trial, and was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamlined review process
Bezuclastinib was also granted the Breakthrough Therapy Designation as a treatment for GIST earlier this year
A2 Bio's A2B543 CAR-T received the FDA fast track designation for certain solid tumors (Ref)
The US FDA granted the fast track designation to A2 Biotherapeutics' A2B543 (logic-gated CAR T-therapy) for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression.
Jim Robinson, CEO, A2 Bio: “Receiving Fast Track designation for A2B543 from the U.S. FDA is a key milestone for A2 Bio in accelerating this promising precision CAR T-cell therapy for cancer patients. We are deeply committed to patients facing cancer and other devastating diseases, and we believe in the potential for A2B543 to address unmet needs in cancer therapy.”
FORE Biotherapeutics' plixorafenib received the FDA breakthrough therapy designation for certain gliomas (Ref)
The US FDA granted the breakthrough therapy designation to FORE Biotherapeutics' plixorafenib (BRAF inhibitor) for the treatment of adult patients with BRAF V600E-mutated high-grade glioma (HGG).
The designation is based on results from the completed Phase 1/2a clinical trial and an ongoing Phase 2 FORTE basket trial evaluating plixorafenib in BRAF V600E-mutated central nervous system (CNS) tumors
Comments