The European Commission has approved the first CAR T-cell therapy to be used in earlier lines of treatment for multiple myeloma patients.

Idecabtagene vicleucel (ide-cel, Abecma), a CAR T-cell therapy by Bristol Myers Squibb, is now approved for European patients who have received at least two prior therapies that include an immunomodulator, a proteasome inhibitor, and an anti-CD38 antibody.

These patients are considered "triple-class exposed" and can now consider CAR T therapy as a potential treatment option. Insurance coverage will also be available for the treatment. 

“As patients with multiple myeloma become exposed to the three main classes of therapy earlier in treatment and still experience relapsed and/or refractory disease, it is critical that we continue to add innovative treatment options to our arsenal that can potentially provide long-term disease control,” said Paula Rodriguez-Otero, M.D., Ph.D., Department of Hematology, Clinica Universidad de Navarra, Pamplona, Spain.

“This expanded approval of ide-cel represents key progress in bringing a personalized therapy that delivers significantly improved, durable outcomes to patients with triple-class exposed relapsed and refractory multiple myeloma after two prior therapies.” 

The approval was based on the KARMMA-3 clinical trial, which showed a 51% reduction in the risk of disease progression and an acceptable safety profile. In the trial, Abecma showed an average progression-free survival of 13.8 months compared to the control arm's 4.4 months.

Abecma was already approved in the United States for patients with four prior lines of therapy, but many can't wait that long to receive this type of treatment. Because these three key drug classes are commonly being used in newly diagnosed care, patients who relapse after these myeloma drug staples are challenged with what to do next. For patients who have exhausted these three drug classes, their median time in remission is only three to five months.

Abecma has shown a consistent safety profile with mostly low-grade and transient occurrences of cytokine release syndrome (CRS) and neurotoxicity. For example, any grade of CRS was seen in 84.6% of patients, but only 5.1% of patients had CRS that was over Grade 3 (more severe). Similarly, for neurotoxicities, any-grade neurotoxicity occurred in 16.1% of patients, with Grade 3/4 neurotoxicity occurring in 3.1% of patients, and no Grade 5 events reported. There were no reported cases of Parkinsonism. 

A recent FDA ODAC (Oncologic Drugs Advisory Committee) meeting was hosted, and the committee majority voted in favor of Abecma approval in earlier lines of therapy. The FDA considers this recommendation as they make their approval decision, but no approval date has been set yet. 

The company states that availability and manufacturing capacity are not issues for patients who want this therapy.

Abecma is also now approved in Switzerland and Japan for similar types of patients with two prior therapy lines. It is also approved in Israel and Great Britain for triple-class exposed relapsed and refractory myeloma patients after three or more prior therapy lines.

Patients in the United States hope to hear a similar approval for them coming soon.