On Friday, Regeneron Pharmaceuticals Inc (NASDAQ:REGN) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional approval of odronextamab for relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
Relapsed/refractory (R/R) follicular lymphoma (FL) refers to cases where FL comes back after initial treatment (relapsed) or doesn't respond to treatment (refractory). Similarly, R/R diffuse large B-cell lymphoma (DLBCL) occurs when DLBCL relapses or doesn't respond to therapy.
The European Commission is expected to announce a final decision in the coming months.
Also Read: Regeneron Pharmaceuticals' Approach To Improve Quality Of Weight Loss Has Merit: Goldman Sachs.
FL and DLBCL are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL).
It is estimated that approximately 120,000 FL cases and 163,000 DLBCL cases are diagnosed annually worldwide. In Europe, it is estimated that approximately 15,000 FL cases and 31,000 DLBCL cases are diagnosed each year.
The positive CHMP opinion is supported by results from the Phase 1 ELM-1 and Phase 2 ELM-2 trials, which demonstrated robust, durable response rates and an acceptable safety profile of odronextamab.
Regeneron continues to evaluate the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas.
This includes the registrational ELM-1 and ELM-2 studies, the Phase 3 OLYMPIA development program, which is one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and additional B-NHLs, and early-stage trials with chemotherapy-free combinations.
In addition to the Phase 3 OLYMPIA development program, Regeneron is investigating odronextamab in combination with a costimulatory bispecific antibody, REGN5837 (CD22xCD28), and Regeneron's cemiplimab for R/R aggressive B-NHL through the ATHENA-1 and CLIO-1 studies, respectively.
Price Action: REGN shares closed at $1,050.86 on Thursday.