NICE recommends all-oral triplet regimen for patients living with relapsed or refractory multiple myeloma
LONDON, UK, 18th January 2023 – Takeda UK Ltd. is pleased to announce that the National Institute for Health and Care Excellence (NICE) has recommended NINLARO (ixazomib) with lenalidomide and dexamethasone as an option for treating RRMM in adult patients who have received two or three lines of therapy, within a final appraisal document (FAD) published today.1
Multiple myeloma is a life-threatening rare blood cancer that arises from the plasma cells, a type of white blood cell that is made in the bone marrow.3 Nearly 6,000 people in the UK are diagnosed each year4 and at any one time, there are around 24,000 people living with multiple myeloma in the UK.3
Ixazomib is the first and only oral proteasome inhibitor licensed in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.5 It has been available through the Cancer Drugs Fund (CDF) since December 2017 for patients who have received two or three prior therapies2 and, to date, has been used to treat over 4,000 patients in England alone.
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. This regimen also provides patients with an all-oral option that allows them the convenience of receiving their treatment in their own homes. 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.”
Commenting further on the decision, Professor Graham Jackson, Consultant Haematologist, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Trust said: “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. 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.”
The recommendation from NICE is based on the results of the Phase 3 TOURMALINE-MM1 study evaluating ixazomib in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone with placebo (control arm).5,6 The data demonstrated that, in patients who had received two or three prior therapies, ixazomib in combination with lenalidomide and dexamethasone improved clinical outcomes compared to lenalidomide and dexamethasone alone (primary endpoint of progression free survival HR 0.617 p=0.033). Adverse events observed in the ixazomib arm were consistent with reported safety profiles for the individual agents.7
Commenting on the FAD, Dr Emma Roffe, Oncology Country Head – UK & Ireland, Takeda UK said: “We are very pleased that the benefit ixazomib has brought to patients and the NHS since December 2017 has been recognised by NICE. The outcome published today reflects many years of perseverance, commitment and passion from Takeda, and the clinical and patient communities, to ensure patients maintain access to an established standard of care for relapsed or refractory multiple myeloma. This appraisal, which originally started in 2016, is a true demonstration of Takeda’s patient-first mindset and our commitment to improving the lives of patients.”
CONTACT
Media in the UK
Emma Roffe
T: +44 (0) 203 549 0907
M: +44 (0) 7810 555052
