Summary of Clinical Use

Initially approved to treat chronic lymphocytic leukemia (CLL) in combination with chemotherapy in patients who have received no prior therapy. In November 2012, this antibody was authorised as an orphan drug by the EMA for the treatment of CLL. Full EMA approval for CLL was granted in July 2014. In February 2016, the US FDA expanded approval to include treatment of patients with follicular lymphoma (FL) who have relapsed after, or are refractory to, a rituximab-containing regimen. This new approval is for a combination therapy of obinutuzumab with bendamustine, followed by obinutuzumab monotherapy. In September 2019 the FDA granted Breakthrough Therapy Designation as a treatment for lupus nephritis, a condition for which there is no currently FDA-approved drug. Results from Phase 2 trial NCT02550652 (NOBILITY study) led to this designation. Obinutuzumab (plus standard of care) demonstrated enhanced efficacy compared to placebo plus standard of care in achieving complete renal response (results to be published) [2].

Mechanism Of Action and Pharmacodynamic Effects

Obinutuzumab acts as an immunomodulator by targeting CD20 and killing B cells.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT02550652	A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)	Phase 2 Interventional	Hoffmann-La Roche

External links

For extended ADME data see the following: Electronic Medicines Compendium (eMC) Drugs.com European Medicines Agency (EMA)