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CoVac-1 induced T-cell responses in about 90% of immunocompromised people with impaired B-cell function.
The CAR-T therapy led to complete remission in 60% of people with relapsed or refractory follicular lymphoma.
Half of patients treated with Breyanzi experienced complete remission, and a majority of these responses were durable.
Umbralisib led to remission in 49% of patients with marginal zone lymphoma and 43% of those with follicular lymphoma.
Approval was based on the results of two clinical trials: AUGMENT and MAGNIFY.
The overall response rate was 50%, with a complete response rate of 32%.
The custom immunotherapy is now indicated for adults with relapsed or refractory lymphoma.
Findings from the JULIET trial support expanded Food and Drug Administration approval of customized T cells.
FDA grants regular approval to obinutuzumab (Gazyva) for adults with previously untreated follicular lymphoma.
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