FDA to Fast Track Review of Experimental Drug HPN217 to Treat Relapsed/Refractory Myeloma


The FDA plans to speed up its review of HPN217 for the treatment of patients with relapsed, refractory multiple myeloma who have received at least four prior lines of therapy.

The experimental drug HPN217 was recently granted a fast track designation by the Food and Drug Administration (FDA), according to HPN217’s developer, Harpoon Therapeutics.

A fast track designation speeds up the process by which the FDA reviews a particular treatment. The goal with a fast-track designation is to quicker fill unmet needs in the treatment of patients who need them most.

HPN217 is a B-cell maturation antigen-targeting tri-specific recombinant protein construct that is to be administered intravenously once a very for approximately one hour. A phase 1/2 study is currently enrolling patients to receive this study treatment.

An estimated 114 patients with relapsed/refractory disease will be administered HPN217 and assessed for safety at increasing dose levels of study drug. The study authors also plan to evaluate the efficacy of the treatment.

Patients enrolled onto the trial must be aged at least 18 years, have relapsed/refractory disease where no standard-of-care options are expected to result in durable remissions and received at least three previous therapies. Patients are to be excluded if they had received a previous autologous stem cell transplant or autologous bone marrow transplantation within 90 days of the beginning of this study.

“We are pleased that HPN217 has received FDA fast track designation because it highlights the serious unmet medical need for patients with relapsed, refractory multiple myeloma who received multiple lines of therapy,” Harpoon Therapeutics’ President and CEO Julie Eastland said in a news release announcing the FDA’s designation. “We are focused on selecting an initial dose to study in the expansion phase of the ongoing Phase 1/2 clinical trial in the first half of this year as we progress HPN217 forward as an innovative new treatment option for these patients.”

If approved, HPN217 would provide patients with another treatment option for relapsed, refractory disease following the recent FDA approval of the CAR-T cell therapy Carvykti (cilta-cel).

That decision was based on data from the CARTITUDE-1 trial, which showed that Carvykti elicited a response to treatment in 98% of patients.

Moreover, after two years of follow-up, more than half of the patients on the trial had yet to experience disease progression.

“On one hand (before the approval of Carvykti), you’re talking about hospice, and on the other hand, (with the use of Carvykti) the cancer has completely disappeared,” Dr. Sundar Jagannath, a professor of Medicine and director of the Multiple Myeloma Center of Excellence at the Tisch Cancer Institute in New York and author on the CARTITUDE-1 study, said in an interview with CURE® about the significance of Carvykti’s approval.

The release did not indicate a date at which the FDA is expected to decide on the approval status of HPN217.

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