European Commission Grants Conditional Marketing Authorization to Teclistamab for Relapsed/Refractory Multiple Myeloma

The European Commission has announced the first global approval of teclistamab for previously treated relapsed/refractory multiple myeloma following its conditional marketing authorization.

Teclistamab (Tecvayli) has received conditional marketing authorization from the European Commission as a treatment for patients with relapsed/refractory multiple myeloma who have underwent treatment with 3 previous therapies, including an immunomodulatory agent, a proteosome inhibitor, and an anti-CD38 antibody, as well as who have progressed on their last therapy, according to a press release from Jansen.1

The regulatory decision marks the first approval for teclistamab worldwide. The approval is based on findings from the phase 1/2 MajesTEC-1 trial (NCT03145181 and NCT04557098) in which patients with relapsed/refractory disease received 1.5 mg/kg of teclistamab after step-up dosing of 0.06 mg/kg and 0.3 mg/kg.2 Data from the trial highlighted and overall response rate of 63% (95% CI, 55.2%-70.4%) among 165 patients following a median of 5 prior lines of therapy. Moreover, a very good partial response rate or better was achieved in 58.8% of patients and the complete response rate or better was achieved in 39.4%.

“Despite important scientific progress, patients who develop relapsed and refractory disease after having been exposed to the three major drug classes have limited therapeutic options and generally face poor outcomes,” Maria-Victoria Mateos, MD, PhD, consultant physician in Haematology at the University Hospital of Salamanca, said in the press release. “Teclistamab has the potential to provide substantial clinical benefit and new hope to these patients, with high rates of deep and durable responses, and the added convenience of being off-the-shelf.”

The FDA received a biologics license application of teclistamab for the treatment of relapsed/refractory multiple myeloma in December 2021.3

References

  1. Janssen marks first approval worldwide for TECVAYLI® (teclistamab) with EC authorisation of first-in-class bispecific antibody for the treatment of patients with multiple myeloma. News release. Jansen. August 24, 2022. Accessed August 24, 2022. https://bit.ly/3wsRYFP
  2. Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. 2022;387(6):95-505. doi:10.1056/NEJMoa2203478
  3. Janssen submits biologics license application to US FDA seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma. News Release. Janssen Pharmaceutical Inc. December 29, 2021. Accessed August 24, 2022. https://bit.ly/3qJ4kpL