The National Institute for Health and Care Excellence (NICE) has recommended lenalidomide as a maintenance treatment for newly diagnosed myeloma patients in England and Wales, reversing an earlier decision to refuse it.
People with multiple myeloma who have undergone an autologous stem cell transplant will now be able to receive lenalidomide. It is the first maintenance treatment for myeloma to be made available through the NHS and is considered the global gold standard for high-dose therapy and stem cell transplantation (HDT-SCT)-eligible patients, NICE said.
The approval comes four months after NICE recommended against approving it. The charity Myeloma UK said it has been working with patients and clinicians to reverse the decision.
Lenalidomide maintenance has been studied in several clinical trials, including Myeloma XI, the largest trial conducted in myeloma with more than 4,000 participants. This trial showed lenalidomide maintenance following HDT-SCT increased remission time and improved overall survival.
Welcoming NICE’s recommendation, Laura Kerby, chief executive of Myeloma UK said: “We are delighted with this outcome. The scale of benefit that this approval can deliver to patients at the start of the myeloma treatment pathway is a hugely significant moment in our history. This decision is a real breakthrough for the future of myeloma treatment.”
She said they presented clear evidence of support from more than 460 patients who completed its patient survey, 98% of whom supported approval.
Professor Graham Jackson, Myeloma XI chief investigator said: “Lenalidomide maintenance is a vital part of the treatment of myeloma patients who have had a stem cell transplant. This treatment prolongs remissions by over two years and is one of the most effective interventions in the treatment of this disease.
“This is a fantastic, welcome and brilliant development and takes us a massive step forwards in myeloma care.”
Lenalidomide costs £3,780 per treatment cycle at its list price, although a confidential commercial arrangement has been agreed with the company that makes it available to the NHS at a discounted price.
Source: NICE/Myeloma UK
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