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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 7 hours ago
- 2 min read
28/05/2026
FDA grants Priority Review to Cogent’s bezuclastinib + sunitinib combo in GIST (Ref)
FDA accepted Cogent’s New Drug Application (NDA) for bezuclastinib + sunitinib in imatinib-pretreated GIST, granting Priority Review with a PDUFA date of November 30, 2026
In PEAK Phase 3 trial, regimen demonstrated statistically significant advantage vs active comparator in GIST
Median PFS: 16.5 months (combo) vs. 9.2 months (sunitinib alone), HR=0.50 (p<0.0001)
ORR: 46% (combo) vs. 26% (sunitinib)
Full PEAK results to be presented at ASCO 2026 (May 30) in an oral abstract session
RenovoRx secures FDA Orphan Drug Designation for oxaliplatin in pancreatic cancer (Ref)
RenovoRx received its third ODD, for oxaliplatin in pancreatic cancer, providing potential seven years of market exclusivity upon approval
This is the second ODD in pancreatic cancer and highlights the versatility of the RenovoCath® dual-balloon infusion catheter for targeted intra-arterial drug delivery
Ongoing Trials - The TIGeR-PaC Phase III trial of intra-arterial gemcitabine (IAG) in locally advanced pancreatic cancer is nearing full enrollment (expected June 2026), with final readout anticipated mid-to-late 2027
Enterome’s EO2463 secures FDA Orphan Drug Designation for indolent NHL (Ref)
EO2463, Enterome’s OncoMimics™ immunotherapy, received U.S. FDA Orphan Drug Designation for indolent non-Hodgkin lymphoma (iNHL) in the “watch-and-wait” setting, adding to its Fast Track designation for follicular lymphoma granted in October 2025
Clinical Data (SIDNEY trial):
Monotherapy: In low-tumor-burden patients, EO2463 achieved 52.6% ORR in follicular lymphoma and 47.6% ORR overall, with complete and partial responses
Combination Therapy: EO2463 with lenalidomide + rituximab showed 60% complete response rate in relapsed/refractory patients, with strong CD8 T-cell expansion
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