Talvey^™ (talquetamab-tgvs) injection was awarded an Accelerated Approval by the U.S. Food and Drug Administration (FDA) on Aug. 9, 2023. The first in a new type of bispecific antibodies, it engages with both cluster of differentiation 3 (CD3) receptors on T cells and G protein-coupled receptor class C group 5 member D (GPRC5D) on multiple myeloma cells and some non-cancer cells. It is indicated to treat adults who have multiple myeloma that has had four or more specific previous treatments. Injections of Talvey are given subcutaneously (SC) in a healthcare facility staffed and equipped to handle any severe side effects that may occur. The first three or four doses ramp up gradually over the first week or 10 days of treatment and then shift to 0.4mg/kg once a week or 0.8mg/kg once every two weeks. During the escalation period, patients should be hospitalized for 48 hours after each dose. Because Talvey has the potential to cause severe side effects that include cytokine release syndrome (CRS) and neurologic toxicities, it has a boxed warning and a risk evaluation and mitigation strategy (REMS). Janssen has not released pricing and launch plans. Here is the full prescribing information.

At a Glance

• Brand (Generic) Name: Talvey (talquetamab-tgvs)
• Manufacturer: the Janssen Pharmaceutical Companies of Johnson & Johnson
• Date Approved: Aug. 9, 2023
• Indication: to treat adults who have relapsed or refractory multiple myeloma that has been treated with 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 3mg/1.5mL or 40mg/mL
• Launch Date: Not yet known
• Estimated Annual Cost: Not yet known
• 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 36,000 new cases of multiple myeloma are diagnosed annually in the U.S. Men are somewhat more likely to have it than women. At about 14%, the risk for African Americans is nearly twice as high as for members of other ethnic groups.
• Talvey causes multiple myeloma cells to disintegrate by connecting GPRC5D proteins on their surfaces with T cells.
• It will be used following treatment failure from four or more previous drug treatments that include a proteasome inhibitor, such as bortezomib; an immunomodulatory agent, such as Revlimid^® (lenalidomide); and an anti-CD38 monoclonal antibody, such as Darzalex^® (daratumumab).
• In the phase II MonumenTal-1 clinical study, over 70% of patients in each dosing group had at least a partial response to Talvey. The average length of response was estimated at approximately nine months for both groups of participants.
• Due to instances of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) among study participants, Talvey has boxed warnings on its labeling and a risk evaluation and mitigation strategy (REMS). Other serious side effects may include blood abnormalities, liver damage, oral toxicity, and serious infections.
• 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^® (teclistamab-cqyv), a bispecific B-cell maturation antigen (BCMA) antibody and CD3 T-cell engager; and two BCMA-directed CAR-T cell therapies, Abecma^® (idecabtagene vicleucel) and Carvykti^™ (ciltacabtagene autoleucel) are also approved as a late-line treatment for multiple myeloma.
• Designated as an Orphan Drug, Talvey is also a Breakthrough Therapy approved under Priority Review.
• Since Accelerated Approval for Talvey is based on results from a phase II clinical study, additional positive results from more advanced trials will be needed before full FDA approval is granted.