FDA Grants Fast Track Designation to Betalutin in R/R Marginal Zone Lymphoma

FDA granted Fast Track designation to lutetium (¹⁷⁷Lu) lilotomab satetraxetan (Betalutin) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have had 2 or more prior lines of systemic therapy.

“We are very pleased to receive Fast Track Designation for Betalutin in MZL, which recognizes the clear need for new therapeutic options for patients with advanced MZL patients who no longer respond to the therapies they have been receiving,” said Lars Nieba, interim chief executive officer, Nordic Nanovector, in a press release. “We are evaluating the opportunity for investigating Betalutin in this important and underserved indication and will provide an update when we have made a decision."

¹⁷⁷Lu lilotomab satetraxetan alone demonstrated encouraging early efficacy in the phase 1/2a LYMRIT 37-01 trial (NCT01796171). The overall response rate (ORR) observed was 78% with a complete response rate of 44% in 9 patients with MZL. The MZL cohort had the highest response rate of all cohorts in the study.

LYMRIT 37-01 is a 2-part study evaluating the efficacy and safety of ¹⁷⁷Lu lilotomab satetraxetan in patients with relapsed non-Hodgkin lymphoma, including MZL, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and mantle cell lymphoma. In part A, phase 1, the primary end point is the maximum tolerated dose, and in part A, phase 2a, the primary end point is tumor response rate. In part B, phase 2b, the primary end point is ORR.

To be eligible for part A of the study, patients are required to have histologically confirmed relapsed disease, with a WHO performance status of 0 to 1, a life expectancy of at least 3 months, measurable disease, less than 25% tumor cell in the bone marrow biopsy and be at least 18 years of age. Eligibility requirements for part B included histologically confirmed relapsed non-Hodgkin B-cell follicular lymphoma, at least 2 prior lines of chemotherapy, a WHO performance status of 0 to 2, a life expectancy of at least 3 months. bone marrow infiltration below 25%, satisfactory lab values and renal function.

With a Fast Track designation, development of ¹⁷⁷Lu lilotomab satetraxetan in the lymphomas landscape will be expedited and reviewed for potential approval by the FDA. The agent previously received an Orphan Drug Designation in the European Union and had submitted an application to the FDA.

_Reference:

_{Nordic Nanovector's Betalutin® receives Fast-Track Designation from US FDA for marginal zone lymphoma. News release. Nordic Nanovector ASA. June 29, 2020. Accessed June 29, 2020. https://bit.ly/31w43vk}