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EMA's CHMP Issues Positive Recommendations for Novartis' Kymriah, Janssen's Carvykti

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday issued a positive recommendation for two autologous CAR T-cell therapies: Novartis' Kymriah (tisagenlecleucel) for previously treated, relapsed or refractory follicular lymphoma and Janssen's Carvykti (ciltacabtagene autoleucel) for previously treated relapsed or refractory multiple myeloma.

The European Commission will now review CHMP's opinions and decide whether to approve the treatments for follicular lymphoma and multiple myeloma patients in the EU.

In the case of Kymriah, the committee recommended the drug for refractory follicular lymphoma patients after two or more lines of systemic therapy. CHMP made the recommendation after reviewing results from the Phase II ELARA trial, in which 69 percent of heavily treated follicular lymphoma patients experienced a complete response following Kymriah. After a median follow-up of 17 months, 86 percent of patients had responded to treatment and 87 percent of patients with a complete response were still in remission.

If the European Commission agrees with CHMP's recommendation and makes Novartis' cell therapy commercially available to follicular lymphoma patients, this will mark Kymriah's third approval in the EU. Already, the therapy is approved in the EU for pediatric or young adult patients with refractory B-cell acute lymphoblastic leukemia and for adult patients with relapsed or refractory diffuse large B-cell lymphoma following two prior lines of treatment.

In January, CHMP recommended that Bristol Myers Squibb's CD19-directed CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) be approved in Europe for previously treated grade 3B follicular lymphoma patients.

For Carvykti, CHMP's recommendation is for heavily treated multiple myeloma patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and progressed on the last therapy.

The opinion was based on data from the Phase Ib/II CARTITUDE-1 study, in which the response rate was 98 percent among 97 evaluable patients. With nearly two years of follow-up, 83 percent of patients treated with cilta-cel achieved a stringent complete response. The two-year progression-free survival rate was 61 percent, and the two-year overall survival rate was 74 percent; median progression-free survival and overall survival were not yet reached.

In October, Novartis also filed for Kymriah approval with the US Food and Drug Administration for this same follicular lymphoma indication. Earlier this month, the FDA approved Janssen's Carvykti for relapsed or refractory follicular lymphoma.