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SMC gives green light for Amgen’s Kyprolis

The committee also gives verdict on three other products

SMCMultiple myeloma patients - who have received at least one prior therapy - in Scotland will soon be able to access Amgen’s Kyprolis (carfilzomib) in combination with dexamethasone via the NHS, following a recommendation by the Scottish Medicines Consortium (SMC).

This is a big milestone for the American biopharma group, as the drug is the first and only proteasome inhibitor to demonstrate improved overall survival.

Tony Patrikios, executive medical director at Amgen UK, said: “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 approval follows recommendation from the National Institute for Health and Care Excellence (NICE) coupled with positive results from the phase III randomised ENDEAVOR trial, which was the first head-to-head clinical study comparing two proteasome inhibitors.

The trial proved that patients treated with Amgen’s combination had a progression free survival (PFS) of 18.7 months while patients on Millennium’s Velcade (bortexomib) and dexamethasone only saw a PFS of 9.4 months.

Patrikios added: “We are pleased with the outcome from the Scottish Medicines Consortium and now patients in England, Wales and Scotland will have access to a treatment with proven evidence to prolong progression-free and overall survival.”

In the UK, it is estimated that there are approximately 17,500 people living with myeloma, accounting for around 2% of all cancers according to Myeloma UK.

Shelagh McKinlay, policy and public affairs officer for Myeloma UK, said: “The approval of carfilzomib and dexamethasone for use on the NHS gives myeloma patients, whose cancer come back, an important new treatment option.

“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 NHS boards in Scotland now have a maximum of 60 days to include carfilzomib in its formularies providing Amgen UK complies with the terms of the agreed patient access scheme.

Continuing with the cancer field, AbbVie’s Venclyxto (venetoclax) also won SMC approval for the treatment of chronic lymphocytic leukaemia (CLL) in adult patients.

Ferring Pharmaceutical’s idiopathic nocturnal polyuria drug Noqdirna (desmopressin oral lypohilisate) also received a green light, however Biofrontera’s Ameluz (aminolaevulinic acid hydrochloride) wasn’t as lucky as the committee said the product was not cost-effective enough to give a recommendation.

Article by
Gemma Jones

9th August 2017

From: Regulatory

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