Dhakal on the FDA Approval of Cilta-Cel for Earlier Lines of RRMM

Binod Dhakal, MD, MS, assistant professor of medicine in the Division of Hematology and Oncology at the Medical College of Wisconsin, discusses the basis of the FDA approval of ciltacabtagene autoleucel (cilta-cel; Carvytki), a chimeric antigen receptor (CAR) T-cell therapy, for relapsed/refractory multiple myeloma that has been treated with at least 1 prior line of therapy, including a proteasome inhibitor and immunomodulatory agent and is refractory to lenalidomide (Revlimid).

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0:09 | Cilta-cel was recently approved by FDA in patients to 1 prior line of therapy, especially in patients who are refractory to lenalidomide and having 1,2,3 prior lines of therapy. So it is important to know the context of the outcomes of these patients with viable therapies. Now, as you know, multiple myeloma is an incurable disease that is mainly characterized by multiple relapses and with each relapse, what happens is that remission periods become shorter and then the disease becomes difficult to treat. That is 1 part.

0:46 | The other part is that with each treatment, the quality of life also gets affected. So health-related quality of life after each relapse will continue to decline. And more importantly, if you look at all the patients who were relapsed and refractory, the median progression-free survival and overall survival is pretty dismal, especially the patients who have been exposed to 3 different plans of therapy.

1:12 | Now, lenalidomide is an important treatment in multiple myeloma and it is kind of used very early on, as early as it is used in induction treatment. And it is used as maintenance and for both transplant eligible and transplant ineligible patients, lenalidomide is kind of an important treatment for patients on this therapy. Now, once the patient's progress after that, that first-line, if you look at the real-world data, the overall progression-free survival with the next line of therapy is not very good, it is about 9 to 10 months at the most, based on the different therapy use.

1:50 | So I think CARTITUDE-4 [NCT04181827], looking specifically at this lenalidomide-refractory patient population, is going to face the gap of the unmet need of new effective therapies for these patients, which can be used very early on. So I think the approval of this in that indication is really kind of an important milestone, and really kind of helps in improving the outcome to these patients.