Combining the proteasome inhibitor Kyprolis (carfilzomib) with dexamethasone is beneficial for adult patients with multiple myeloma who have received at least one prior therapy, the Scottish Medicines Consortium (SMC) determined.
The SMC advises the Scottish National Health Service (NHS) boards and their Area Drug and Therapeutics Committees (ADTCs) on the clinical and cost effectiveness of all newly licensed medicines. The SMC’s recommendation, which followed meetings with patient groups and clinical specialists, will now guide NHS Scotland’s use of Kyprolis.
“This is great news for patients in Scotland. The approval of carfilzomib and dexamethasone for use on the NHS gives myeloma patients, whose cancer has come back, an important new treatment option,” Shelagh McKinlay, policy and public affairs officer at Myeloma UK, said in a press release. “We are especially pleased that the approval covers all patients who have had one prior treatment as carfilzomib and dexamethasone has been shown to be very effective in prolonging survival in relapsed myeloma patients, and should be available to doctors as a prescribing option for their eligible patients.”
The decision to support the combination therapy was based on positive results from the ENDEAVOR Phase 3 trial (NCT01568866), announced last July. The study, which recruited 929 patients with multiple myeloma who relapsed after one to three prior therapies, compared the effectiveness of two proteasome inhibitors, Kyprolis and Velcade (bortezomib), together with dexamethasone. The trial’s primary outcome was to measure patients’ progression-free survival (PFS).
The results showed that patients in the Kyprolis arm lived almost twice as long without showing signs of cancer progression compared with the Velcade arm, at 18.7 months versus 9.4 months, respectively.
An interim analysis of patients’ overall survival (OS) showed that Kyprolis led to an increase of survival by 7.6 months over Velcade. The study’s median OS was 47.6 months for patients treated with Kyprolis compared with 40 months for patients in the Velcade group.
“We are pleased with the outcome from the Scottish Medicines Consortium, which follows the recent National Institute for Health and Care Excellence’s recommendation for carfilzomib. This means that suitable patients in England, Wales and Scotland will have access to a treatment with proven evidence to prolong progression-free and overall survival,” said Tony Patrikios, executive medical director at Amgen U.K. and Ireland. “We know that time free of disease is precious and we are committed to advancing care for people with this difficult-to-treat blood cancer. We see carfilzomib as the backbone therapy for the management of relapsed multiple myeloma.”
The NHS boards in Scotland have 60 days to include Kyprolis as a treatment option for adult patients with multiple myeloma who have received at least one prior therapy.