FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma

myeloma abstract cells PAP

What is the potential role for teclistamab-cqyv in the treatment of multiple myeloma?

  • Teclistamab is a bispecific T-cell engager (BiTE) monoclonal antibody that binds to the CD3 receptor expressed on T-cells and binds to B-cell maturation antigen (BCMA) expressed on multiple myeloma cells. The bispecific antibody allows the T-cell to come into proximity with the multiple myeloma cell, which has been shown to result in cell lysis in vitro.1
  • Teclistamab is approved for patients with relapsed or refractory multiple myeloma who received at least 4 prior lines of therapy including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody. Approval was based on data collected in MajesTEC-1 Trial.2,3
  • MajesTEC-1 was a single-arm, multi-cohort, open-label, multi-center, phase 1/2 study. Patients (N=165) had relapsed or refractory multiple myeloma and had progressed on at least three lines of therapy. The study excluded patients previously treated with BCMA-targeted therapy.3
    • The primary endpoint measured was objective response rate (ORR), defined as a partial response or better.
    • Secondary endpoints included duration of response, very good partial response or better, complete response or better, progression-free survival (PFS), and overall survival (OS).
  • Responses occurred in 63.0% of patients; 58.8% of responses were considered very good partial responses and 39.4% of responses were considered complete responses. Median time to first response was 1.2 months (range, 0.2-5.5) and median time to a best response was 3.8 months (range, 1.1-16.8).3
    • Response rates were generally lower in patients with extramedullary disease, stage III disease, and at least 60% marrow replacement by plasma cells. Patients that received no more than 3 lines of previous therapy were more likely to respond to teclistamab3.
  • Key secondary endpoints:3
    • Median duration of response:
      • 18.4 months (95% CI, 14.9 to not estimable)
    • Median PFS:
      • 11.3 months (95% CI, 8.8-17.1)
    • Median OS:
      • 18.3 months (95% CI, 15.1 to not estimable)
  • Safety
    • 94.5% of patients experienced grade 3 or 4 adverse effects.
      • Most common adverse effects of any grade were hematologic
        • Neutropenia (70.9%)
        • Anemia (52.1%)
        • Thrombocytopenia (40.0%)
      • Infections occurred in 76.4% of patients
        • Grade 3 or 4 infections occurred in 44.8% of patients.
    • Cytokine release syndrome (CRS) occurred in 72.9% of patients. CRS events were mostly grade 1 or 2 and fully resolved.
      • CRS most commonly occurred following step-up dosing and after cycle 1 dose.
      • Only 3.6% of patients had CRS in cycle 2 or later.
      • Median onset of CRS was 2 days (range, 1-6) after the most recent dose.
      • Various supportive care treatments were administered to patients experiencing CRS, including tocilizumab, low-flow nasal cannula oxygen, and corticosteroids.
    • Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 3.0% of patients
      • ICANS events were all grade 1 or 2.
  • National Comprehensive Cancer Network (NCCN) guidelines make a category 2A recommendation for the use of teclistamab in relapsed or refractory multiple myeloma after at least four prior lines of therapy that included an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody.4
    • Other agents that can be considered for this patient population per NCCN guidelines include idecabtagene vicleucel and ciltacabtagene autoleucel.
  • Teclistamab is the first approved BiTE in relapsed or refractory multiple myeloma. Many other BiTE therapies are under investigation in his space, including elranatamab which recently received FDA and EMA filing acceptance.5,6
  • BiTE monoclonal antibodies continue to be investigated in relapsed or refractory multiple myeloma and have been shown to be highly efficacious, even in heavily pretreated patients. Their use in the treatment of multiple myeloma will likely continue to evolve.6

What role can the pharmacist play in the management of patients on teclistamab-cqyv?

  • Teclistamab is a subcutaneous injection that has an initial step-up dosing schedule followed by weekly dosing.1
    • Step-up dosing schedule:
      • Day 1: 0.06 mg/kg
      • Day 4: 0.3 mg/kg
      • Day 7: 1.5 mg/kg
    • Weekly dosing starting 1 week after day 7 of step-up dosing:
      • 1.5 mg/kg
    • Continue therapy until disease progression or unacceptable toxicity.
    • The package insert also provides recommendations on how to dose teclistamab following dose delays or when restarting therapy. Dosing changes are based on the duration of time the patient was off therapy.
  • Hospitalization is recommended for 48 hours following administration of all step-up doses due to the risk of CRS.1
    • Risk of CRS decreases dramatically following step-up dosing.3
    • The FDA requires a risk evaluation and mitigation strategy (REMS) due to the risk of CRS and ICANS.7
    • Patients should be premedicated with dexamethasone (16 mg), acetaminophen, and diphenhydramine prior to step-up doses.3
  • There are no dose reductions for toxicity, but dose delays may be indicated based on toxicity.
  • There are no dose adjustments recommended for renal or hepatic impairment.
  • There are specific recommendations for CRS management based on CRS grading.
  • It is possible that cytokine release can result in cytochrome P450 (CYP) enzyme suppression resulting in higher serum concentration of CYP substrates. Monitor for adverse effects relating to decreased clearance of CYP substrates. This is most likely to occur within 7 days of initiating therapy or following CRS.8

Clinical Pearls

  • Step-up dosing is required when initiating teclistamab for relapsed or refractory multiple myeloma.1,3
    • Hospitalization is required for 48 hours following each step-up dose administration.
  • Hematologic toxicity and infections are common adverse effects seen in patients treated with teclistamab.3
    • Consider the need for infection prophylaxis as indicated.
  • Syringes can be refrigerated or left at room temperature for 20 hours if they are drawn up and not used immediately.1
  • The Janssen CarePath Savings Program for TECVAYLI™ can assist patients with out-of-pocket cost for teclistamab.9


1.Tecvayli (Teclistamab) [package insert]. Beerse, Belgium: Janssen Pharmaceuticals; 2022.

2.U.S. Food and Drug Administration. FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma. Accessed June 18, 2023.

3.Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):495-505. doi:10.1056/NEJMoa2203478.

4.National Comprehensive Cancer Network. Multiple Myeloma (Version 3. 2023). https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed June 18, 2023.

5.Pfizer Press Release: Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-elranatamab-receives-fda-and-ema-filing-acceptance. Accessed June 18, 2023.

6.Swan D, Murphy P, Glavey S, Quinn J. Bispecific antibodies in multiple myeloma: opportunities to enhance efficacy and improve safety. Cancers (Basel). 2023;15(6):1819. doi:10.3390/cancers15061819.

7.Tecvayli Risk Evaluation and Mitigation Strategy (REMS). https://tecvaylirems.com/#Main. Accessed June 18, 2023.

8.Hua G, Scanlan R, Straining R, Carlson DS. Teclistamab-cqyv: the first bispecific T-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma. J Adv Pract Oncol. 2023;14(2):163-171. doi:10.6004/jadpro.2023.14.2.7.

9.Janssen CarePath Savings Program for TECVAYLI™. https://www.tecvayli.com/helpful-resources. Accessed July 1, 2023

Gavyn Walsh

PD3 Oncology Pharmacy Intern

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