AbbVie's EPKINLY approved by FDA for follicular lymphoma

AbbVie has received accelerated approval from the US Food and Drug Administration (FDA) for its new therapeutic drug, EPKINLY (epcoritamab-bysp), specifically designed to treat adult patients with relapsed or refractory follicular lymphoma (R/R FL). This drug is a T-cell engaging bispecific antibody intended for subcutaneous administration, targeting patients who have undergone at least two previous lines of therapy.

The FDA's approval was primarily based on the overall response rate and the durability of the response observed in clinical trials. To ensure continued approval, the clinical benefits of EPKINLY will need to be validated in confirmatory trials. Epcoritamab, developed through a partnership between AbbVie and Genmab, will be commercially available in the US and Japan through their joint efforts. Globally, AbbVie will handle the commercialization of the drug.

The decision by the FDA was supported by data from the Phase I/II EPCORE NHL-1 clinical trial. This trial evaluated the safety and efficacy of EPKINLY in 127 patients who had received a median of three prior therapies. Notably, 70% of these patients had double refractory disease. The trial’s primary endpoint was the overall response rate, which was 82% for patients treated with EPKINLY. Of these patients, 60% achieved a complete response, and 22% had a partial response. At a median follow-up of 14.8 months, the median duration of response had not been reached, indicating sustained efficacy in over half of the responding patients.

Common adverse reactions reported during the trial included injection site reactions, cytokine release syndrome, and Covid-19. Mariana Cota Stirner, AbbVie’s head of the haematology therapeutic area and vice-president, highlighted the significant and lasting responses observed with EPKINLY treatment. She noted the convenience of subcutaneous dosing, which does not require mandatory hospitalization and utilizes a three-step-up dosing regimen.

Stirner expressed optimism about EPKINLY's potential to become a core therapy for multiple B-cell malignancies. She emphasized AbbVie's commitment to advancing cancer research and improving standards of care for patients.

This approval follows an earlier development where the US FDA issued a complete response letter regarding AbbVie’s new drug application for ABBV-951, aimed at treating motor fluctuations in adult patients with advanced Parkinson’s disease.