1st bispecific antibody Epkinly approved with a condition

Approved with the condition of submitting Phase III trial results

MFDS CPAC deems the drug’s approval adequate subject to the condition of therapeutic confirmatory clinical trial Data

'Epkinly (epcoritamab),' the first T-cell–engaging bispecific antibody, was found to have been approved under the condition that the company submits Phase III trial data.

 

In Korea, the approval was granted on March 20 based on Phase II clinical trial data and a Phase III trial protocol, but at the time, a condition was added that the company must submit data from a therapeutic confirmatory trial.

 

According to the minutes of the Central Pharmaceutical Affairs Committee meeting held in April, which were recently released by the Ministry of Food and Drug Safety, Epkinly was granted conditional approval and was required to submit Phase III trial results after the approval of the product by applying Article 24, Paragraph 3 of the 'Regulations for Approval and Review of Biological Products, etc.

 

'Epkinly (epcoritamab),’ which is imported by Abbvie Korea, is a bispecific monoclonal antibody that binds to both the CD3 on the surface of T-cells and CD20 on the surface of B-cells and is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after 2 or more lines of systemic therapy In Korea, Polivy, Kymriah, Selinexor, and Columvi are approved for the treatment of patients with relapsed or refractory DLBCL.

 

DLBCL is one of the most common blood cancers and is one of the most common types of widely spread (diffuse) non-Hodgkin lymphoma, characterized by rapid progression.

 

Epkinly binds to CD3 to activate T cells and binds to CD20 to bring B cells to the side of activated T cells and induce B cell death.

 

In this regard, a CPAC member said, "In a clinical trial in patients with persistent relapses requiring 3 or more cycles of treatment, Epkinly demonstrated some degree of effectiveness and safety.

 

Its effectiveness and safety have been confirmed over other existing drugs, so we deemed granting conditional marketing authorization was appropriate pending the results of its Phase III clinical trial." When the U.S.

 

FDA granted the drug through its accelerated approval program, the approval was based on the Phase I/II EPCORE NHL-1 study.

 

In 148 patients with relapsed or refractory DLBCL who had received a median of 3 prior therapies, the drug demonstrated an objective response rate of 61%, a complete response rate of 38%, and a median duration of response of 15.6 months in patients with CD20-positive diffuse large B-cell lymphoma.

 

Another CPAC member added, "Based on the Phase II results, Epkinly appears to be an effective and safe agent when compared to other 2nd or later line agents.

 

Therefore, we believed the conditional approval was warranted, subject to submission of its Phase III results."