NICE Recommends J&J's Tecvayli for Relapsed and Refractory Multiple Myeloma

Johnson & Johnson’s (J&J) Tecvayli (teclistamab) has received a recommendation from the National Institute for Health and Care Excellence (NICE) for treating adults in England and Wales who have relapsed and refractory multiple myeloma (RRMM). This recommendation is targeted specifically at patients who have previously undergone at least three treatments, have seen progression in their disease after their last treatment, and are otherwise eligible for pomalidomide combined with dexamethasone (pom-dex).

Multiple myeloma is a serious and incurable blood cancer that impacts plasma cells, a type of white blood cell. In the UK, approximately 5,900 individuals are diagnosed with this condition annually. Most of these patients experience relapses and need subsequent therapies, with the effectiveness of treatments decreasing with each new line of therapy.

Tecvayli is administered as a subcutaneous injection and functions as a bispecific antibody. It operates by redirecting T cells towards multiple myeloma cells, aiding in their destruction. The decision by NICE to recommend Tecvayli was influenced by clinical trial results, which indicated that RRMM patients treated with Tecvayli after three prior therapies had a median overall survival of 22 months and a median progression-free survival of 11 months. Further data illustrated that Tecvayli reduces the risk of disease progression by 44% and the risk of death by 48% when compared to pom-dex.

Amanda Cunnington, senior director of patient access at J&J Innovative Medicine UK, highlighted the challenges faced by multiple myeloma patients, particularly the issue of recurrent relapses. She emphasized the importance of having access to novel treatment options that can offer the potential for sustained remission and an improved quality of life. Despite expressing satisfaction with the draft guidance meeting the needs of most patients, Cunnington also voiced concern about the proposed restriction by NICE, which could exclude some patients who have been anticipating the availability of Tecvayli through the NHS.

This recommendation for Tecvayli comes shortly after J&J received approvals from both the European Commission (EC) and the US Food and Drug Administration for another treatment, Sirturo (bedaquiline), intended for tuberculosis. Additionally, J&J’s bispecific antibody Rybrevant (amivantamab) was recently approved by the EC for use in combination with carboplatin and pemetrexed chemotherapy as a first-line treatment for non-small cell lung cancer in adults with specific genetic mutations.