EMA Gives Positive CHMP Opinion for Teclistamab Relapsed/Refractory Myeloma Indication

The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended conditional marketing approval to teclistamab (Tecvayli) as a treatment for patients with relapsed/refractory multiple myeloma who have undergone treatment with at least 3 previous therapies—including an immunomodulatory agent, a proteosome inhibitor, and an anti-CD38 agent—and who progressed on their last line of treatment, according to a press release from Johnson & Johnson.¹

This is the first time the regulatory organization has given a positive opinion to a T-cell redirecting bispecific antibody for adult patients with relapsed/refractory disease. The opinion was based on findings from the phase 2 MajesTEC-1 trial (NCT04557098), which assessed the off-the-shelf cellular therapy in patients with relapsed/refractory disease.² In a population of 165 patients, the overall response rate was 63.0% at a median follow-up of 14.1 months. Moreover, the complete response rate was 39.4% and the minimal residual disease negativity rate was 26.7%.

“We endeavor to deliver our robust multiple myeloma pipeline of diverse mechanisms and targets with the aim of improving outcomes for patients,” Peter Lebowitz, MD, PhD, Global Therapeutic Area Head of Oncology at Janssen Research & Development, LLC, said in a news release. “Teclistamab is testament to this approach. If adopted by the European Commission, the approval could be the first worldwide for teclistamab, as the first T-cell redirecting bispecific antibody for the treatment of patients with relapsed and refractory multiple myeloma.”

Most recently, a biologics license application for teclistamab was submitted to the FDA for patients with relapsed/refractory multiple myeloma in January 2022 based on findings from the phase 1/2 MajesTEC-1 study (NCT03145181).³

References

1. Janssen receives positive CHMP opinion for novel bispecific antibody TECVAYLI® (teclistamab) for the treatment of patients with relapsed and refractory multiple myeloma (RRMM). News release. July 22, 2022. Accessed July 26, 2022. https://bit.ly/3PAY9PZ
2. Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. N Engl J Med. Published online June 22, 2022. 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 July 27, 2022. https://bit.ly/3qJ4kpL