FDA rejects Roche's Columvi in earlier diffuse large B-cell lymphoma, citing lackluster US data
18th July 2025 Uncategorised 0The other shoe has dropped for Roche’s bid to move Columvi into earlier treatment of diffuse large B-cell lymphoma in the U.S. In a complete response letter, the FDA suggested that Roche’s phase 3 Starglo data do not provide enough evidence to support the proposed indication in a U.S. population, according to the company.
More: FDA rejects Roche's Columvi in earlier diffuse large B-cell lymphoma, citing lackluster US data
Source: fierce