FDA go-ahead to Roche’s one-minute follicular lymphoma therapy
Full approval will depend on verification of clinical benefit in a confirmatory trial
Full approval will depend on verification of clinical benefit in a confirmatory trial
The FDA aims to make a decision by April 8, 2026
Golcadomide, a CELMoD agent, continued to deliver deep and durable responses in aggressive B-cell and follicular lymphomas
Columvi combined with gemcitabine and oxaliplatin dramatically extends survival in people with relapsed or refractory diffuse large B-cell lymphoma
The one-time CAR T cell infusion now becomes the first and only therapy of its kind cleared for this patient population
LYMPHIR addresses a clear clinical need in a disease with limited treatment options
The European Commission’s green light marks Breyanzi’s fourth indication in Europe and extends access to patients across all EU and EEA countries
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
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