Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Intranet
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

FDA Accepts sBLA for Genentech/Roche’s Columvi® Combination Therapy

Dec 4, 2024

On 4 October 2024, Genentech and Roche announced that the US FDA has accepted Roche’s supplemental biologics licence application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant.  Genentech expects approval by 20 July 2025.

Columvi® has been previously approved in the US for the treatment of adults with R/R DLBCL or LBCL arising from follicular lymphoma, after two or more lines of systemic therapy.

This news follows the addition of Columvi® to Australia’s Therapeutic Goods Administration list of prescription medicines for evaluation for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma in September 2024.