STARGLO

STARGLO, trial NCT04408638 sponsored by Roche and published in the Lancet in 2024, showed that the CD20 by CD3 bispecific glofitamab with gemcitabine and oxaliplatin improved survival over rituximab plus the same chemotherapy in relapsed or refractory diffuse large B-cell lymphoma in transplant-ineligible patients. It randomised 274 patients, met its primary overall survival endpoint with a large progression benefit, and won EU approval in 2025.

The United States went the other way, and what is on the public record is this. On 20 May 2025 the Oncologic Drugs Advisory Committee discussed supplemental biologics licence application 761309/S-001 for Columvi, for use with gemcitabine and oxaliplatin in adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who are not candidates for autologous stem cell transplant. The committee was asked whether the STARGLO population and trial results are applicable to the proposed US patient population and voted No 8, Yes 1, Abstain 0. The FDA's own minutes record the reasons: the limited number of US patients enrolled, inconsistencies between Asian and non-Asian populations, non-adherence to the ICH E17 guidance on multiregional trials, and subgroup analyses showing inferior results in non-Asian patients across overall survival, progression-free survival, response rate and complete response. The glofitamab label effective 25 June 2026 still carries only the accelerated approval after two or more lines, so the second-line indication was not granted. OnCo has previously recorded a complete response letter here, citing a trade publication; the FDA does not routinely publish complete response letters and no primary source for one was found, so the claim has been replaced with what the agency's own documents say. Whether regional heterogeneity reflected biology, practice or chance is the open question.