FDA accepts supplemental Biologics License Application for Roche's Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
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The FDA has accepted Roche's supplemental Biologics License Application for Columvi in combination with GemOx for treating relapsed or refractory diffuse large B-cell lymphoma. A decision is expected by July 2025.
December 05, 2024 | 6:15 am
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Roche's sBLA for Columvi in combination with GemOx has been accepted by the FDA for treating relapsed or refractory DLBCL. The FDA decision is anticipated by July 2025.
The acceptance of the sBLA by the FDA is a positive regulatory step for Roche, potentially leading to expanded use of Columvi. This could positively impact Roche's stock price as it may lead to increased sales if approved.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90