Roche's Bispecific Antibody With Fixed-Duration Treatment Scores FDA Approval For Type Of Lymphoma
Portfolio Pulse from Vandana Singh
The FDA has granted accelerated approval to Roche's Columvi (glofitamab-gxbm) for the treatment of relapsed or refractory diffuse large B-cell lymphoma and large B-cell lymphoma arising from follicular lymphoma. The approval is based on the phase 1/2 NP30179 study results, which showed durable remission in patients treated with fixed-duration Columvi.

June 16, 2023 | 2:16 pm
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Roche's Columvi receives FDA accelerated approval for the treatment of certain types of lymphoma, potentially boosting the company's market presence.
The FDA's accelerated approval of Roche's Columvi for the treatment of relapsed or refractory diffuse large B-cell lymphoma and large B-cell lymphoma arising from follicular lymphoma is a positive development for the company. This approval could lead to increased market presence and potential revenue growth for Roche in the oncology sector. The phase 1/2 NP30179 study results showed promising outcomes, with durable remission in patients treated with fixed-duration Columvi.
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