Tecvayli Recommended for Conditional Approval in Europe
A branch of the European Medicines Agency (EMA) has recommended that Janssen’s investigational therapy Tecvayli (teclistamab) be granted conditional marketing authorization for adults with relapsed and refractory multiple myeloma (RRMM).
The recommendation, from the EMA’s Committee for Medicinal Products for Human Use (CHMP), specifically supports Tecvayli for patients whose disease has progressed after receiving at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and a CD38 inhibitor. The recommendation will be reviewed by the European Commission, which will issue a final decision in the coming months.
Conditional marketing authorization, or CMA, is a form of approval that can be granted to medications that address a serious medical need where the benefit of making the therapy immediately available outweighs the risk. CMA is granted based on less comprehensive data than normally required but the therapy’s developer has to provide additional data in the future.
The EMA granted accelerated assessment to Tecvayli late last year. This designation, which shortens the CHMP review time, is given when a medicinal product is of major interest for public health and therapeutic innovation.
“Our ambition to eliminate multiple myeloma is stronger today than ever before. We aim to reach this goal by investing in cutting-edge innovations that address individual patient needs and offer healthcare professionals options they have not had before,” Edmond Chan, MD, senior director EMEA therapeutic area lead for haematology at Janssen-Cilag, said in a press release.
“Today’s recommendation from the CHMP marks exciting progress in this journey, and we look forward to working with health authorities to make [Tecvayli] available to patients across the region, as soon as possible,” Chan said.
Tecvayli is an antibody-based therapy designed to trigger the immune system to kill myeloma cells. It’s designed to simultaneously bind to BCMA, a marker found on myeloma cells, and to CD3, a protein expressed by cancer-killing immune cells called T-cells. Janssen sought approval of Tecvayli in the U.S. earlier this year.
“If adopted by the European Commission, the approval could be the first worldwide for [Tecvayli], as the first T-cell redirecting bispecific antibody for the treatment of patients with relapsed and refractory multiple myeloma,” said Peter Lebowitz, MD, PhD, global therapeutic area head for oncology at Janssen Research and Development.
CHMP’s recommendation was based on data from an open-label Phase 1 clinical trial (NCT03145181) and Phase 2 clinical trial (NCT04557098) called the MajesTEC-1 study that’s testing Tecvayli in adults with RRMM. The Phase 1 part of the study is still recruiting participants at sites in the U.S. and Europe, while Phase 2 is recruiting in the U.S., Europe, and China.
Data from 165 patients in the trial, all of whom had received three prior lines of therapy, showed an overall response rate of 63% over a median follow-up of 14 months. More than one in three (39.4%) patients had a complete response, 46% of whom had no evidence of residual disease.
The most common side effects were an inflammatory reaction called cytokine release syndrome, which was generally not serious, and reduced counts of immune cells called neutrophils (neutropenia), which was more commonly serious than not. Infections were reported in more than three-quarters of patients and nearly half were considered serious.
Neurotoxic events were reported in 14.5% of patients and 3% had immune effector cell-associated neurotoxicity syndrome (a condition where neurotoxicity is driven by an inflammatory immune response). There were five deaths related to treatment.