FDA Grants Roche Accelerated Approval for Lymphoma Therapeutics
June 23, 2023
The US Food and Drug Administration (FDA) has granted Roche accelerated approval for Columvi, its antibody-based therapeutics for two aggressive forms of lymphoma. Results from a phase 1/2 study found the drug provided durable remission for over half of patients and a complete response for 43%, with 66% continuing to respond for 9 months or longer.
According to Emily Kimber, “The authorisation specifically applies to patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. Around 160,000 people worldwide are estimated to be diagnosed each year with DLBCL – the most common form of non-Hodgkin’s lymphoma. The disease can develop at any age, but the majority patients are diagnosed at age 65 or older.”
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(Source: PM Live, June 23rd, 2023)
