The most common side effects include cytokine release syndrome, muscle and bone pain, rash, and tiredness.[11]
It was approved for medical use in Canada in July 2023,[3][12] in the United States in June 2023,[13][14] and in the European Union in July 2023.[8][15]
Glofitamab is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma.[7][13] Specifically it is indicated for the treatment of adults with certain types of diffuse large B-cell lymphoma or large B-cell lymphoma who have received at least two prior treatments that did not work or are no longer working.[11]
The FDA approved glofitamab based on evidence from a clinical trial NP30179 (NCT03075696) of 145 participants with large B-cell lymphoma who received at least one dose of glofitamab.[11] The efficacy of glofitamab was assessed in 132 participants with de novo diffuse large B‑cell lymphoma, not otherwise specified (80%) or large B-cell lymphoma arising from follicular lymphoma (20%), who have received at least two prior lines of therapy and who received at least one dose of glofitamab.[11] The trial was conducted at 32 sites in 13 of countries in Australia, Belgium, Canada, Czech Republic, Denmark, Spain, Finland, France, Italy, New Zealand, Poland, Taiwan, and the United States.[11] The benefit and side effects of glofitamab were also evaluated in the clinical trial.[11] All participants received glofitamab until the disease progressed or the side effects became too toxic.[11]
In April 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Columvi, intended for the treatment of diffuse large B‑cell lymphoma (DLBCL).[16] The applicant for this medicinal product is Roche Registration GmbH.[16] Glofitamab was approved for medical use in the European Union in July 2023.[8]
^ ab"Columvi: Pending EC decision". European Medicines Agency. 26 April 2023. Archived from the original on 28 April 2023. Retrieved 27 April 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information. 34 (1). hdl:10665/339768.
Clinical trial number NCT03075696 for "A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma" at ClinicalTrials.gov
This article incorporates text from this source, which is in the public domain.
