RE:RE:RE:RE:ONCY pelareorep + CD3 bispecific antibody true-killer comboJune 15, 2023 - The FDA has granted an accelerated approval to Roche’s Columvi, or glofitamab - a D20xCD3 bispecific T-cell engager, to treat diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma arising from follicular lymphoma in patients who’ve tried at least two prior lines of systemic therapy.
In the phase 2 trial that supported Columvi’s approval, 68% of patients who had previously achieved no sign of cancer remained in complete remission at 18 months, according to an update shared at ASCO. Those are encouraging signs that Columvi’s effect is durable despite patients stopping treatment after 8.5 months.
An accelerated approval means Roche still needs to provide confirmatory data.
Columvi is Roche’s second CD20xCD3 T-cell engager to reach the market.
https://www.fiercepharma.com/pharma/game-abbvie-roches-columvi-nabs-fda-approval-2nd-bispecific-large-b-cell-lymphoma