Ninlaro® (ixazomib) plus lenalidomide and dexamethasone has been recommended by NICE for relapsed/refractory multiple myeloma patients who have had two or three lines of therapy.
The National Institute for Health and Care Excellence (NICE) has recommended Ninlaro® (ixazomib) with lenalidomide and dexamethasone for treating relapsed/refractory multiple myeloma (RRMM).
The final appraisal document (FAD) recommended the triple regimen as an option for adult patients who have received two or three lines of therapy.
Shelagh McKinlay, Head of Patient Advocacy at Myeloma UK stated: “There aren’t many treatment options for patients in the third-line setting… This regimen also provides patients with an all-oral option that allows them the convenience of receiving their treatment in their own homes.”
Takeda UK’s ixazomib is the first and only oral proteasome inhibitor licensed in combination with lenalidomide and dexamethasone for adults with multiple myeloma (MM) who have received at least one prior therapy.
Professor Graham Jackson, Consultant Haematologist at Freeman Hospital, Newcastle upon Tyne Hospitals NHS Trust commented: “This treatment has become an important standard of care in relapsed or refractory multiple myeloma over the past five years, so I am delighted with this final decision from NICE.”
“For the thousands of people living with multiple myeloma in England, Wales and Northern Ireland, this decision brings reassurance that ixazomib in the NICE approved setting is now routinely available on the NHS,” McKinlay added.
The Phase III trial for relapsed/refractory multiple myeloma
The recommendation from NICE is based on the results of the Phase III TOURMALINE-MM1 study. It evaluated 722 patients given ixazomib in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone with placebo (control arm).
The data demonstrated that ixazomib in combination with lenalidomide and dexamethasone improved clinical outcomes compared to lenalidomide and dexamethasone alone (primary endpoint of progression free survival (PFS) HR 0.617 p=0.033). Adverse events (AEs) observed in the ixazomib arm were consistent with reported safety profiles for the individual agents.
Regulatory approvals for ixazomib (NINLARO®) capsules
In 2016 the European Commission (EC) issued a marketing authorisation for ixazomib in combination with lenalidomide and dexamethasone for adults with MM who have received at least one prior therapy.
Ixazomib is currently approved in more than 65 countries, including the UK, US, Japan and in the European Union (EU). It was the first oral proteasome inhibitor to enter Phase III clinical trials and to receive a regulatory approval.
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