Johnson & Johnson and Partner Legend Biotech’s Cell Therapy Now Available FDA Approved For the treatment of multiple myeloma, providing a new treatment option for patients with the most severe cases of this type of cancer.
The J&J drug, called Carvykti, is part of a personalized one-time cancer treatment called CAR T, which is made by engineering a patient’s T cells to track specific targets on the surface of cancer cells. In Carvykti’s case, the target is a protein, B cell maturation agent (BCMA), which is abundant on the surface of multiple myeloma cells. The FDA approval of Carvykti late Monday made the drug the second approved BCMA-targeting agent for multiple myeloma. Abecma, a CAR T-cell therapy from Bristol Myers Squibb and partner 2Seventybio, won regulatory approval last year.
Multiple myeloma is a blood cancer that affects plasma cells, a type of white blood cell found in the bone marrow. These cancerous plasma cells spread and replace healthy cells, forming tumors in the bone marrow. It’s a relatively rare cancer, estimated to have occurred in about 34,920 of the roughly 1.9 million cancer cases diagnosed last year. American Cancer Society.
While both Abecma and Carvykti are pursuing BCMA, J&J Cell Therapeutics expresses the receptor with two single-domain antibodies that target BCMA, which the company says makes it more capable of binding to the target cancer protein. Carvykti’s approval covers its use in adults with multiple myeloma relapses or who have not responded to four or more earlier treatments, putting it on par with Abecma’s drug label. The FDA’s decision to approve Carvykti is based on data from the pivotal Phase 1b/2 clinical trial. The open-label study enrolled patients who had received at least third-line therapy.
Preliminary data for the first 29 patients are report At the American Society of Clinical Oncology 2020 Annual Meeting, showed an overall response rate to treatment of 100% and a strict complete response rate of 76% (22 patients). The updated data for 97 patients is came up with At the annual meeting of the American Society of Hematology. The results showed an overall response rate of 98%, with 83% of patients showing a strict complete response at a median follow-up of 22 months.
Carvykti’s drug label carries a boxed warning to alert clinicians and patients that the drug may cause a dangerous immune response called cytokine release syndrome; neurotoxicity; Parkinson’s disease; and Guillain-Barre syndrome, which It is an immune response that affects the nerves. Drug labels for Abecma and other CAR T drugs carry similar warnings. Like Abecma, the new J&J cell therapy can only be offered under a program that informs clinicians and patients about the risks of treatment.
Carvykti’s approval came later than initially expected.In November last year, Johnson & Johnson Announce The FDA needs more time to review other information the company has submitted at the agency’s request. This pushed the target date for the decision to February 28.
Carvykti was originally developed by Legend Biotech, a China-based company with U.S. operations in Somerset, NJ. In 2017, Johnson & Johnson subsidiary Janssen signed a global licensing and collaboration agreement with Legend Biotech covering cell therapy development and commercialization. According to the agreement, the two companies will share the production and commercialization costs of the cell therapy, as well as global drug profits excluding China, which will allocate 70% to Lenovo and 30% to Janssen.
Janssen has set the wholesale price at $465,000, up from the $419,500 BMS announced after Abecma’s approval. Janssen said in an emailed statement that the price “reflects the significant clinical value of this cell therapy in addressing unmet medical needs in patients with limited treatment options and heavily pretreated. We expect Carvykti to be used by most Commercial payers and Medicare are covered as medical benefits.”
Photo: Niels Wenstedt/BSR Agency, Getty Images
