Takeda’s Ninlaro (ixazomib) with lenalidomide and dexamethasone has been recommended by the National Institute for Health and Care Excellence (NICE) to treat adult patients with relapsed or refractory multiple myeloma (RRMM) who have received two or three lines of therapy, the company announced.
The decision from NICE was based on results from the phase 3 TOURMALINE-MM1 study which showed that, in patients who had received two or three prior therapies, the all-oral triplet therapy improved clinical outcomes compared to lenalidomide and dexamethasone alone.
Adverse events observed in the ixazomib arm were consistent with reported safety profiles for the individual agents, the company reported.
Multiple myeloma is a life-threatening rare blood cancer affecting plasma cells found in bone marrow. Nearly 6,000 people in the UK are diagnosed with the disease each year and at any one time, there are around 24,000 people living with multiple myeloma in the UK.
As the disease progresses, relapses for patients become more aggressive with each new line of therapy and remissions become progressively shorter.
In 2016, the European Commission issued a marketing authorisation for the triplet therapy as a treatment for adult patients with multiple myeloma who had received at least one prior therapy. Ixazomib is currently approved in more than 65 countries.
The drug has been available through the Cancer Drugs Fund since December 2017 for patients who have received two or three prior therapies and, to date, has been used to treat over 4,000 patients in England alone.
This latest decision from NICE means that patients will now have routine access to the all-oral triplet therapy.
Shelagh McKinlay, head of patient advocacy at Myeloma UK, said: “We have been working with NICE and other stakeholders for several years to ensure access to this therapy is maintained and we are thrilled with the outcome of this appraisal.
“There aren’t many treatment options for patients in the third-line setting, which is why maintaining access to ixazomib was so critically important.”
Commenting further on NICE’s decision, Professor Graham Jackson, consultant haematologist, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Trust said: “It has been quite a journey to ensure this valuable treatment continues to be available to patients and the clinical and patient communities have engaged fully in the process. This welcome decision gives us more certainty in the treatment options available to our patients.”