FDA ODAC favors 2 CAR T-cell therapies for multiple myeloma

A meeting of the United States FDA Oncologic Drugs Advisory Committee (ODAC) voted to expand the approval of Abecma and Carvykti, two types of chimeric antigen receptor (CAR) T-cell therapies, for multiple myeloma, allowing them to be used as an earlier line of defense.

Abecma is already approved in the US as a treatment for patients with relapsed or refractory multiple myeloma in individuals who have had four or more lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 inhibitor.

It is a type of CAR T-cell therapy that binds to B-cell maturation antigens (BCMA) found on the surface of multiple myeloma cells. As the first BCMA-directed CAR T-cell immunotherapy approved in the US, the medication causes CAR T-cell proliferation, cytokine secretion, and cytolytic killing of the multiple myeloma cells that express BCMAs.

Based on a Phase 3 clinical study that presented a favorable risk–benefit profile, ODAC voted to approve Abecma for patients with triple-class exposed relapsed or refractory multiple myeloma in an 8-3 vote.

While the advisory vote is a recommendation, it may contribute to the FDA’s final decision on the drug.

“The favorable and supportive outcome of the ODAC meeting brings us another step closer to expanding the benefits of Abecma to myeloma patients earlier in their treatment course,” said Anna Truppel-Hartmann, senior vice president, Clinical Research and Development, 2seventy bio, in the Bristol Myers Squibb press release. “We believe in the strength of the KarMMa-3 data and remain committed to increasing treatment options and improving outcomes for patients living with multiple myeloma.”

Beyond Abecma, the committee unanimously voted to approve Carvykti with relapsed or refractory multiple myeloma, who has received at least one prior line of therapy.

Carvykti was previously approved in February 2022 by the FDA as a fifth-line treatment for adults with relapsed or refractory multiple myeloma. It is also a BCMA-directed CAR T-cell immunotherapy.

Again, the vote by ODAC was based on results from a phase 3 clinical trial and may contribute to final approval down the line.

“We are pleased with the advisory committee’s support for CARVYKTI in earlier lines of treatment based on the CARTITUDE-4 data,” said Jordan Schecter, MD, Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine, the Johnson & Johnson press release. “As a physician and researcher committed to advancing patient care, the potential of CARVYKTI in earlier lines of therapy represents an important therapeutic option for patients with multiple myeloma.”