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.
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.
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.
Two studies report on thoracic radiotherapy for lung cancer: a phase III trial found adding radiotherapy to chemoimmunotherapy did not improve survival in extensive-stage small cell lung cancer, while a retrospective review showed high local control rates with single-fraction 28 Gy stereotactic body radiotherapy.
The FDA has accepted an NDA for iberdomide in combination with anti-CD38 antibodies for relapsed or refractory multiple myeloma. A phase 2 study reports a 39% near complete response rate for the DaraKPd quadruplet therapy with durable MRD negativity. Preclinical research shows the RXR agonist IRX4204 sensitizes myeloma cells to ferroptosis and enhances lenalidomide efficacy.
The FDA has accepted for review a New Drug Application for tirabrutinib, a Bruton tyrosine kinase inhibitor, for relapsed or refractory primary central nervous system lymphoma. The application is based on phase 2 PROSPECT trial data showing an overall response rate of 67% and complete response rate of 44%. The target action date is December 18, 2026.
The phase III frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP chemotherapy reduced the risk of progression by 25% in patients with high-risk B-cell lymphomas. The 3-year progression-free survival was 67.3% with the combination versus 60.7% with R-CHOP alone. A dual-targeted CD19/CD20 immunotherapy regimen has also been approved in Australia for relapsed follicular lymphoma.
Three trials show ultra-low-dose checkpoint inhibitors retain efficacy with reduced toxicity and dramatically lower costs. DELII and Patil et al. trials tested low-dose nivolumab in solid tumors and HNSCC; NIVIPIT tested intratumoral low-dose ipilimumab in melanoma.
An interim phase 3 analysis showed mezigdomide plus carfilzomib and dexamethasone reduced the risk of progression or death in relapsed/refractory multiple myeloma. The SUCCESSOR-2 study remains ongoing and will assess overall survival and safety.
