On Oct. 25, 2022, the U.S. Food and Drug Administration (FDA) granted Accelerated Approval for Janssen Biotech’s Tecvayli™ (teclistamab-cqyv). The first bispecific B-cell maturation antigen (BCMA) antibody and cluster of differentiation 3 (CD3) T-cell engager, is indicated for the treatment of multiple myeloma that has returned or that has become resistant despite four or more specific previous therapies. Unlike some similar drugs that target BCMA, Tecvayli is not derived from the patient’s cells. It is given by subcutaneous (SC) injection. Its recommended “step-up” dosing is 0.06mg/kg on the first day, 0.3mg/kg on the fourth day, and 1.5mg/kg on the seventh day. Then, maintenance is at 1.5mg/kg once per week. Tecvayli will only be available through a risk evaluation and mitigation strategy (REMS) because using it may be associated with potentially fatal side effects. Tecvayli is expected to be launched in two to three weeks. Here is prescribing information.

At a Glance

• Brand (Generic) Name: Tecvayli (teclistamab-cqyv)
• Manufacturer: Janssen Biotech
• Date Approved: Oct. 25, 2022
• Indication: to treat adults who have relapsed or refractory multiple myeloma and who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
• Dosage Forms Available: single-dose vials containing either 30mg/3mL or 153mg/1.7mL for SC administration
• Launch Date: It will be launched within two to three weeks.
• Estimated Annual Cost: Pricing information is not yet available.
• Multiple myeloma is a progressive, incurable blood cancer that affects plasma cells. A type of white blood cell found in bone marrow, plasma cells are matured B cells that produce antibodies. When damaged, they rapidly displace normal cells and create tumors in the bone marrow.
• The American Cancer Society (ACS) estimates that about 35,000 new cases of multiple myeloma are diagnosed annually in the U.S. Men are somewhat more likely to have it than women and; at about 14%, the risk for African Americans is nearly twice as high as for members of other ethnic groups. The five-year survival rate is more than 50% across all stages of the condition.
• The numerous other drugs available to treat multiple myeloma include several chemotherapy (chemo) regimens and some targeted therapies. High doses of chemo followed by stem cell transplants also are used for patients who can tolerate them. Resistance eventually develops to most pharmaceutical therapies, however; and many patients suffer relapses.
• Tecvayli reprograms CD3 on T-cells to attack BCMA, which is abundant on the surfaces of multiple myeloma cells.
• Tecvayli will be used following treatment failure from four or more prior treatments that include proteasome inhibitors, such as bortezomib; immunomodulatory agents, such as lenalidomide; and anti-CD38 monoclonal antibodies, such as Darzalex^® (daratumumab).
• In phase I/II Majestic-1 clinical trial, the average time to response was 1.2 months, 62% of the 150 patients achieved at least some response to Tecvayli and 59% had a progression-free survival (PFS) time of nine months or longer.
• Blood abnormalities such as anemia and neutropenia affected 50% or more of the study participants and 72% had milder forms of cytokine release syndrome (CRS), a potentially severe acute inflammatory reaction. Other adverse effects included fatigue and injection site reactions.
• Blenrep (belantamab mafodotin-blmf – GlaxoSmithKline), an antibody-drug conjugate; and two BCMA-directed CAR-T cell therapies, Abecma® (idecabtagene vicleucel – Bristol Myers Squibb/bluebird bio) and Carvykti™ (ciltacabtagene autoleucel – Janssen/Legend) are also approved as a late-line treatment for multiple myeloma.
• Tecvayli has a Breakthrough Therapy designation and Orphan Drug status.