Regeneron enters Phase 3 in Korea

Phase 3 clinical trials for Regeneron's new lymphoma treatment drug Odronextamab are being conducted in Korea

FDA and EMA review begins in the second half of this year for CD20 and CD3 targeted treatments.

 

Phase 3 clinical trials for Regeneron's new lymphoma treatment drug Odronextamab are being conducted in Korea.

 

The Ministry of Food and Drug Safety recently submitted an application from ICON Clinical Research Korea for the efficacy and safety of Odronextamab (REGN1979), an anti-CD20/anti-CD3 bispecific antibody used in combination with Lenalidomide in subjects with relapsed/refractory follicular lymphoma and marginal zone lymphoma.

 

A phase 3, open-label, randomized clinical trial (OLYMPIA-5) was approved to compare rituximab in combination with lenalidomide.

 

It can be viewed as a clinical trial for approval of a wide range of indications as an initial treatment for lymphoma and additional treatment for B-cell non-Hodgkin lymphoma.

 

Odronextamab is a type of CD20 Follicular lymphoma and diffuse large B-cell lymphoma are the most frequently occurring subtypes of B-cell non-Hodgkin lymphoma.

 

The European Medicines Agency (EMA) received PanMAA in August for the treatment of adult patients with relapsed or refractory follicular lymphoma or relapsed or refractory diffuse large B-cell lymphoma that has progressed after at least two prior systemic treatments.

 

Subsequently, the US FDA accepted the application for priority review approval as a third-line therapy for the same indication in September.

 

The target date for final approval is reportedly March 31 next year.

 

It is expected to be the fourth dual antibody treatment targeting CD20·CD3 to receive FDA approval, following Roche's 'Lunsumio', AbbVie's Epkinly, and Roche's Columvi.

 

Lunsumio', the first CD20·CD3 targeting dual antibody treatment approved by the FDA, received product approval in Korea on the 3rd.

 

Following Epkinly and Columvi, if Odronextamab receives FDA approval, it is expected to take steps for domestic approval.