The bispecific antibody is used to treat patients with relapsed or refractory multiple myeloma (R/R MM) who have achieved and maintained a complete response for at least 6 months; this approval allows a dosing frequency of 1.5 mg/kg every 2 weeks.
Johnson & Johnson announced this week that the FDA has approved biweekly dosing for teclistamab (Tecvayli), its bispecific antibody used to treat patients with relapsed or refractory multiple myeloma (MM) who have achieved and maintained a complete response (CR) for at least 6 months. The new approval allows a dosing frequency of 1.5 mg/kg every 2 weeks.
The therapy, given subcutaneously, was first approved in October 2022 for patients who had been treated with at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody. Teclistamab targets B-cell maturation antigen (BCMA) on MM cells and CD3 on T cells to trigger an immune response.
According to a statement from Johnson & Johnson, teclistamab has been prescribed to more than 3600 patients in the United States since its approval. This latest approval is based results for a group of patients in the phase 1/2 MajesTEC-1 study (NCT03145181, NCT04557098) who were first treated with the recommended phase 2 dose of 1.5 mg/kg once weekly; if patients achieved a CR or better for 6 months or longer (phase 2), they were eligible to reduce dosing frequency to every 2 weeks until their disease progressed or they experience unacceptable toxicity.
“[Teclistamab] is the only BCMA-targeted immune-based therapy with weight-based dosing,” Rachel Kobos, MD, vice president, Oncology Research & Development, Johnson & Johnson Innovative Medicine, said in a statement. “As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, [teclistamab] is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma.”
Adverse events from teclistamab can include cytokine release syndrome and neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome.
Reference
Tecvayli (teclistamab-cqyv) biweekly dosing approved by the US FDA for the treatment of patients with relapsed or refractory multiple myeloma. News release. Johnson & Johnson. February 20, 2024. Accessed February 23, 2024. https://www.jnj.com/media-center/press-releases/tecvayli-teclistamab-cqyv-biweekly-dosing-approved-by-the-u-s-fda-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma
CAR T Proves Effective and Safe for Refractory Multiple Myeloma
May 15th 2024Due to increasing reports of multiple myeloma and the emergence of chimeric antigen receptor (CAR) T-cell therapy as a treatment option, these investigators conducted a comprehensive review of the medical literature on the latest CAR T developments in the MM space.
Read More
Tisotumab Vedotin Gains Full FDA Approval for Recurrent or Metastatic Cervical Cancer
April 30th 2024The FDA granted full approval for tisotumab vedotin-tftv to treat recurrent or metastatic cervical cancer that progressed after chemotherapy, offering patients improved overall survival and a manageable safety profile.
Read More
What We’re Reading: FDA Approves UTI Antibiotic; Ozempic, Wegovy Price Investigation; US Births Fall
April 25th 2024The FDA recently approved an antibiotic for the treatment of urinary tract infections (UTIs) in women; a Senate committee recently launched an investigation into the prices of Novo Nordisk’s diabetes and weight loss drugs; US births fell last year, resuming a national slide after a previous increase during the pandemic.
Read More