FDA Approves Earlier Use of Carvykti for Multiple Myeloma Patients

The FDA has broadened the approved use of Carvykti, a CAR-T cell therapy developed by Johnson & Johnson and Legend Biotech, for treating multiple myeloma. Previously designated as a fifth-line treatment, Carvykti can now be administered to patients who have undergone at least one prior therapy. This significant label expansion positions Carvykti as an option much earlier in the treatment process, potentially benefiting a larger patient population.

In 2022, Carvykti garnered $500 million in global sales as a later treatment option. Following the FDA’s latest approval, sales are projected to reach $950 million this year, indicating the therapy’s growing impact in the multiple myeloma treatment landscape. The decision opens treatment with Carvykti to a broader group of patients, specifically targeting those previously treated with a proteasome inhibitor and an immunomodulatory agent and are refractory to lenalidomide.

Despite the expansion, Legend Biotech’s CEO, Ying Huang, anticipates that the majority of Carvykti recipients in the near term will continue to be patients who are further along in their treatment journey. However, there’s a notable emphasis on the therapy’s potential for second-line patients, who may benefit from its application earlier due to less compromised immune systems from previous treatments.

This label expansion for Carvykti follows a similar move for Bristol Myers Squibb and 2seventy bio’s Abecma, another CAR-T therapy for multiple myeloma, now approved as a third-line treatment. Both therapies have shown significant potential in improving patient outcomes, though they come with warnings and precautions about early deaths observed in clinical studies. Despite these concerns, the long-term survival benefits of Carvykti have been deemed to outweigh the risks, as evidenced by its effectiveness in reducing the risk of disease progression or death in the CARTITUDE-4 Phase 3 study.

As the adoption of Carvykti grows, J&J and Legend Biotech are focusing on expanding manufacturing capacity to meet demand. The companies are also addressing supply constraints that have previously hindered the therapy’s broader use. With regulatory recommendations in Europe and ongoing discussions about the risks and benefits of CAR-T therapies, the landscape for multiple myeloma treatment continues to evolve, highlighting the significance of innovative approaches in cancer care.

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[Source: Endpoints, April 6th, 2024]