The submission is supported by data from MajesTEC-1, a multicenter clinical trial evaluating the safety and efficacy of teclistamab in adults with RRMM.
Janssen has submitted a Biologics License Application for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody, for the treatment of patients with relapsed or refractory multiple myeloma (RRMM), according to a press release.
“Despite all the gains that have been made in treating multiple myeloma, the unmet need still remains very high. Our relentless pursuit of treatments for this disease continues with the same sense of urgency that we have always had,” said Peter Lebowitz, MD, PhD, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC, in the press release. “We look forward to working with the FDA in their review of our teclistamab submission.”
The submission is supported by data from MajesTEC-1, a multicenter clinical trial evaluating the safety and efficacy of teclistamab in adults with RRMM. The study assessed efficacy outcomes, such as overall response rate, very good partial response, and complete response using International Myeloma Working Group criteria and the safety profile of teclistamab.
“The deep expertise, creativity and persistence of the entire Janssen R&D organization enabled the expeditious advancement of teclistamab for multiple myeloma,” said Mathai Mammen, MD, PhD, Global Head, Janssen Research & Development, Johnson & Johnson, in the press release. “Today’s submission is another important step in our commitment to bring to patients truly transformational medicines that profoundly impact their health.”
Teclistamab is being evaluated currently in multiple monotherapy and combination studies.
Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. Janssen. December 29, 2021. Accessed January 5, 2022. https://www.janssen.com/janssen-submits-biologics-license-application-us-fda-seeking-approval-teclistamab-treatment-patients