Johnson & Johnson’s (J&J) Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat adults in England and Wales with relapsed and refractory multiple myeloma (RRMM).
The draft guidance specifically applies to patients who have received at least three prior treatments, have progressed on their last treatment, and would otherwise be offered pomalidomide plus dexamethasone (pom-dex).
Approximately 5,900 people are diagnosed in the UK every year with multiple myeloma, an incurable blood cancer that affects a type of white blood cell called plasma cells.
The majority of patients will relapse and require subsequent therapy, with efficacy declining after each line of treatment.
Administered as a subcutaneous injection, Tecvayli is a bispecific antibody that works by redirecting T cells to multiple myeloma cells and helping to destroy them.
NICE’s decision was supported by clinical trial results showing that RRMM patients who received Tecvayli after three prior therapies had a median overall survival of 22 months and a median progression-free survival of 11 months.
Further data comparing Tecvayli to pom-dex demonstrated that J&J’s therapy reduces the risk of disease progression by 44% and the risk of death by 48%.
Amanda Cunnington, senior director of patient access, J&J Innovative Medicine UK, said: “Patients with multiple myeloma face several challenges – not least coping with recurrent relapses – and it’s vital that they can access novel treatment options that offer the potential for sustained remission and improved quality of life.”
Cunnington added that, while the draft guidance “meets the needs” of the majority of these patients, the company is “very concerned” that the proposed restriction applied by NICE removes this option from those who have been waiting for Tecvayli to become available on the NHS.
The recommendation comes just over two weeks after J&J received approvals from both the European Commission (EC) and the US Food and Drug Administration for its tuberculosis treatment, Sirturo (bedaquiline).
In addition, the company’s bispecific antibody Rybrevant (amivantamab) was recently approved by the EC for use alongside carboplatin and pemetrexed chemotherapy as a first-line treatment for non-small cell lung cancer in adults with epidermal growth factor receptor exon 20 insertion mutations.