The FDA granted breakthrough therapy designation to subcutaneous amivantamab for recurrent or metastatic HPV-unrelated HNSCC after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The decision was supported by OrigAMI-4 cohort 1 data showing a 45% ORR and 76% clinical benefit rate.
Lyell Immunopharma initiated the Phase 3 PiNACLE–H2H trial of ronde-cel in large B-cell lymphoma and reported that GI prophylaxis reduced severe diarrhea rates from 55% to 10% in the Phase 1 LYL273 trial.
A phase 3 trial of azacitidine and chidamide plus CHOP in untreated PTCL showed a significant overall survival improvement but no significant gains in response rate or progression-free survival. The study suggests molecular profiling could guide future therapies.
FDA approved zenocutuzumab-zbco (Bizengri) for NRG1 fusion-positive cholangiocarcinoma on May 8, 2026. The eNRGy trial showed a 36.8% ORR. It also received priority review, breakthrough, and orphan designations.
FDA approved subcutaneous isatuximab-irfc for multiple myeloma. Phase 3 EMN24 trial showed 77% MRD negativity with Isa-KRd quadruplet therapy. Phase 2 study showed 77% hematologic response rate in relapsed/refractory AL amyloidosis.
Epcoritamab plus lenalidomide cut progression risk by 60% in R/R DLBCL in a phase 3 trial. Five-year AUGMENT follow-up supports R2 in indolent NHL; a phase 2 penpulimab-lenalidomide-R-GemOx trial showed activity in DLBCL.
The U.S. FDA has accepted for filing a New Drug Application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary central nervous system lymphoma, setting a PDUFA action date of December 18, 2026. The submission is supported by Phase 2 PROSPECT study results showing a 67% overall response rate and 44% complete response rate. If approved, tirabrutinib would be the first BTK inhibitor commercially available in the U.S. for this indication.
The FDA approved pivekimab sunirine-pvzy (Decnupaz) for adults with BPDCN on May 27, 2026, based on CADENZA trial data showing a 69.7% CR/CRc rate in treatment-naïve patients.
Updated data from the phase I CaMMouflage trial showed CB-011, the first allogeneic anti-BCMA CAR-T therapy with immune cloaking, achieved an approximately 92% overall response rate in relapsed/refractory multiple myeloma. The 2026 Tandem Meetings also highlighted advances in EB-103, KITE-753, and LV20.19 CAR-T constructs across lymphoma and CLL. Separately, NXC-201 reported a 95% complete response rate in AL amyloidosis.
Real-world studies show early complete response after CAR T-cell therapy predicts sustained remission in large B-cell lymphoma, while historical chemotherapy yields poor outcomes in high-risk patients. Data from registries highlight a significant event-free survival advantage for second-line axicabtagene ciloleucel versus standard-of-care salvage therapy.
