Phase I CARLYSLE trial data show CAR-T therapy obe-cel induces remission in severe refractory lupus with a favorable safety profile. Separate case report documents two successful pregnancies after dual-target CAR-T therapy with no transmission to infants.
Swissmedic has authorized three orphan drugs for rare diseases: Breyanzi for mantle cell lymphoma, Alhemo for haemophilia A and B, and Ekterly for hereditary angioedema. The decisions include a new indication extension for Breyanzi, an expanded indication for Alhemo, and the initial authorization of Ekterly as part of a joint international regulatory initiative.
China has approved the world's first CAR-T cell therapy for solid tumors, specifically for stomach cancer, developed by CARsgen Therapeutics. Meanwhile, the WVU Cancer Institute has conducted the first-ever use of a subcutaneous formulation of blinatumomab to achieve remission in a patient with ultra-rare mixed phenotype acute leukemia.
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.
A Cleveland Clinic study found no racial survival disparities in multiple myeloma when patients have equal access to modern therapies. Clinical cases demonstrate long-term remission with second stem cell transplants and targeted agents like daratumumab.
Long-term results from the phase III TRIANGLE trial show ibrutinib-based regimens improve survival in younger mantle cell lymphoma patients, while the ECHO trial establishes a new standard for older patients. Advances in CAR T-cell and bispecific antibody therapies are reshaping treatment for this rare blood cancer. The findings were presented at the annual MCL Consortium meeting.
Multiple market reports forecast the global biologics and antibody therapy markets will reach hundreds of billions of dollars by the 2030s, driven by monoclonal antibodies, biosimilar expansion, and targeted therapies.
The treatment landscape for multiple myeloma is evolving rapidly with T-cell engaging therapies like bispecific antibodies and CAR T-cell treatments shifting care toward a chronic condition with potential treatment breaks. This evolution is creating new side effect management challenges and complicating clinical trial design as sponsors grapple with selecting comparator arms and adapting to a rapidly shifting standard of care.
CARsgen Therapeutics has signed a RMB370 million agreement to build a CAR T-cell manufacturing base in Shanghai, supporting commercialization of its marketed and late-stage products. Meanwhile, investment firm HarbourVest disclosed a $21 million position in CAR-T developer Generate Biomedicines, which holds $516.6 million in cash after its IPO.
