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EMA Recommends Granting a Conditional Marketing Authorisation for Teclistamab

It is indicated as monotherapy in adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies
19 Aug 2022
Multiple Myeloma

On 21 July 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product teclistamab (Tecvayli), intended for treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies.

Tecvayli was supported through EMA’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 CHMP reviewed the application for marketing authorisation under an accelerated timetable to enable faster patient access to this medicine.

The applicant for this medicinal product is Janssen-Cilag International N.V.

Tecvayli will be available as 10 mg/ml and 90 mg/ml solutions for injection. The active substance of Tecvayli is teclistamab, a bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells.

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.

The benefit of Tecvayli is its ability to bring about a response in patients with relapsed and refractory multiple myeloma.

The CHMP based its recommendation for a conditional marketing authorisation on a phase I/II, multicentre, open label, single-arm clinical study. 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. In total, 63% of patients enrolled in the study responded to the treatment with Tecvayli, and median progression-free survival was 18 months.

The most common side effects reported in the clinical study for Tecvayli were hypogammaglobulinaemia, cytokine release syndrome, and neutropenia.

The full indication is:

Tecvayli is indicated as monotherapy 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 have demonstrated disease progression on the last therapy.

Tecvayli should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is expected to provide comprehensive clinical data at a later stage.

In order to better characterise the safety and effectiveness of the medicine, the company will have to submit data from a randomised phase III 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 EU Member State, taking into account the potential role or use of this medicine in the context of the national health system of that country.

This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.

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