EMA has recommended a conditional marketing authorisation in the European Union (EU) for Tecvayli (teclistamab) for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment.

Multiple myeloma is a rare cancer of a type of white blood cells called plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system. Plasma cells make the antibodies that enable the body to recognise and attack germs, such as viruses or bacteria. In multiple myeloma, the division of plasma cells becomes uncontrolled, resulting in abnormal, immature plasma cells multiplying and filling up the bone marrow. When plasma cells become cancerous, they no longer protect the body from infections and produce abnormal proteins that can cause problems affecting the kidneys, bones or blood.

A range of new medicines for the treatment of multiple myeloma have been developed and approved in recent years, leading to a steady overall improvement in patient survival. However, for patients who have already been treated with three major classes of drugs (immunomodulatory agents, proteasome inhibitors and monoclonal antibodies) and no longer respond to these drugs, the outlook is still bleak. Therefore, new medicines are needed for these patients.

Tecvayli is a monoclonal antibody that targets two proteins at the same time: a protein called B-cell maturation antigen (BCMA), which is present on the surface of the multiple myeloma cells, and CD3, a protein that is present on T cells (cells of the immune system responsible for destroying abnormal cells). By attaching to BCMA and CD3 at the same time, the medicine activates the T cells to kill the multiple myeloma cells.

Tecvayli was supported throughEMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. EMA’s human medicines committee (CHMP) reviewed the application for marketing authorisation under an accelerated timetable to enable faster patient access to this medicine.

The CHMP based its recommendation for a conditional marketing authorisation on a phase 1/2, multicentre, open label, single-arm clinical trial. The study investigated the efficacy and safety of Tecvayli in 165 patients with relapsed or refractory multiple myeloma who had received at least three prior therapies (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody) and who didn’t respond to the last treatment regimen. 63% of patients enrolled in the study responded to the treatment with Tecvayli and lived without their disease getting worse for about 18 months on average. The most common side effects reported in the clinical trial for Tecvayli were hypogammaglobulinaemia (a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high), cytokine release syndrome (CRS) (i.e. a condition causing fever, vomiting, shortness of breath, headache and low blood pressure), and neutropenia (low levels of neutrophils, a type of white blood cell).

Tecvayli is recommended for a conditional marketing authorisation, one of the EU regulatory mechanisms to facilitate early access to medicines that fulfil an unmet medical need. This type of approval allows the Agency to recommend a medicine for marketing authorisation with less complete data than normally expected, if the benefit of a medicine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available.

In order to better characterise the safety and effectiveness of the medicine, the company will have to submit data from a randomised phase 3 confirmatory study comparing the efficacy of teclistamab in combination with daratumumab SC with the treatment regimen daratumumab SC, pomalidomide, and dexamethasone (DPd) or daratumumab SC, bortezomib, and dexamethasone (DVd) in adults with relapsed or refractory multiple myeloma. The company is also required to submit the final results of the pivotal study.

The opinion adopted by the CHMP is an intermediary step on Tecvayli’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role or use of this medicine in the context of the national health system of that country.

Notes

  • The applicant for Tecvayli is Janssen-Cilag International N.V.
  • Tecvayli was accepted into the PRIME scheme on 29 January 2021.
  • Tecvayli was designated as an orphan medicinal product on 19 October 2020.
  • Following this positive CHMP opinion, the Committee for Orphan Medicinal Products (COMP) will assess whether the orphan designation should be maintained.

Share this page