Scottish Medicines Consortium Accepts Amgen's Multiple Myeloma Treatment, KYPROLIS® ▼ (carfilzomib), in Combination with Dexamethasone, for use at First Relapse

CAMBRIDGE, England, August 8, 2017 /PRNewswire/ --

• Carfilzomib Accepted in Combination with Dexamethasone Alone for the Treatment of Adult Patients with Multiple Myeloma who have Received At least One Prior Therapy
• Patients Treated with Carfilzomib in Combination with Dexamethasone Showed a Significant Increase in Progression-Free Survival Compared to Bortezomib with Dexamethasone
• Carfilzomib is the First and Only Proteasome Inhibitor to Demonstrate Statistically Significant Improved Overall Survival in a Head-to-Head Trial

Today, the Scottish Medicines Consortium (SMC) has published its advice accepting the use of KYPROLIS (carfilzomib) in combination with dexamethasone alone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The advice takes into account the continuing availability of the Patient Access Scheme (PAS) agreed or a list price that is equivalent or lower.^[1]

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The SMC advice guides NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on the use of carfilzomib within NHS Scotland. It has taken into account the views of patient group representatives and clinical specialists in a Patient and Clinical Engagement (PACE) meeting.^[1]

"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," said Shelagh McKinlay, Policy and Public Affairs Officer, Myeloma UK. "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."

Clinical experts consulted by the SMC considered that carfilzomib plus dexamethasone is a therapeutic advance as it provides an opportunity to increase overall and progression-free survival when compared to bortezomib plus dexamethasone; one of the current standard of care for relapsed multiple myeloma. It also concluded that carfilzomib is associated with a reduced rate of peripheral neuropathy.^[1]

The key evidence to support the use of carfilzomib in combination with dexamethasone in the treatment of adults with relapsed multiple myeloma was based on the large Phase 3 randomised study, ENDEAVOR (n=929). This first ever head-to-head clinical trial, comparing two proteasome inhibitors, showed that adults treated with carfilzomib plus dexamethasone lived almost twice as long without their cancer progressing (progression-free survival; PFS) compared to bortezomib plus dexamethasone (18.7 months vs. 9.4 months).^[2] Moreover, in a planned interim analysis of overall survival (OS), carfilzomib and dexamethasone (Kd) reduced the risk of death by 21 percent compared to bortezomib and dexamethasone (Vd), resulting in a 7.6 month survival benefit (median OS 47.6 months for Kd versus 40.0 for Vd, HR=0.79; 95 percent CI: 0.65 - 0.96; p=0.01).^[3]

"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 UK 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."

In the UK, it is estimated that there are approximately 17,500 people living with myeloma^[4] and it accounts for around two percent of all cancers.^[4] In Scotland, it is estimated that there are 473 new cases and 273 deaths due to multiple myeloma each year.^[5] It is estimated that over 1,300 patients will be eligible for treatment rising to over 1,700 patients by year five.^[1]

Following the publication of the SMC's advice, NHS Boards in Scotland now have a maximum of 60 days to include carfilzomib in their formularies for the treatment of patients with multiple myeloma who have received at least one prior therapy. The advice is contingent upon Amgen UK providing carfilzomib to NHS Scotland within the terms of the agreed PAS.

Please refer to the Summary of Product Characteristics for full prescribing information: https://www.medicines.org.uk/emc/medicine/31222.

About carfilzomib (KYPROLIS^®) for Injection 

Carfilzomib is an irreversible proteasome inhibitor for use in the treatment of adults with multiple myeloma after one prior treatment. Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.^[6] Carfilzomib has been shown to block proteasomes leading to an excessive build-up of proteins within cells.^[7] Carfilzomib can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.^[7]

Important European Union Product Safety Information for Carfilzomib 

▼ This medicinal product is subject to additional monitoring. Adverse events should be reported. Reporting forms and information can be found at http://www.mhra.gov.uk/yellowcard . Adverse events should also be reported to Amgen Limited on +44(0)1223-436441.

Carfilzomib treatment should be supervised by a physician experienced in the use of anti-cancer therapy. The most serious side effects that may occur during carfilzomib treatment include cardiac toxicity, pulmonary toxicities, pulmonary hypertension, dyspnoea, hypertension including hypertensive crises, acute renal failure, tumour lysis syndrome, infusion reactions, thrombocytopenia, hepatic toxicity, posterior reversible encephalopathy syndrome (PRES) and thrombotic thrombocytopenic purpura/haemolytic uremic syndrome (TTP/HUS).

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit http://www.amgen.co.uk.

References: 

^[1] SMC Detailed Advice Document carfilzomib 10mg, 30mg, 60mg powder for solution for infusion (Kyprolis®). SMC No. (1242/17). Available at: http://www.scottishmedicines.org.uk . Accessed August 2017.

^[2] Dimopoulos, Meletios A et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. The Lancet Oncology. 2016;17(1):27-38.

^[3] Dimopoulos, Meletios A et al. Overall Survival of Patients with Relapsed or Refractory Multiple Myeloma Treated with Carfilzomib and Dexamethasone versus Bortezomib and Dexamethasone in the Randomized Phase 3 ENDEAVOR Trial. Abstract: 16th International Myeloma Workshop. March 2017.

^[4] Myeloma UK - Myeloma: Essential Guide. Available at: https://www.myeloma.org.uk/wp-content/uploads/2013/09/Myeloma-UK-Living-well-with-Myeloma-Essential-Guide.pdf . Accessed August 2017.

^[5] ISD Scotland Cancer Statistics Multiple Myeloma. Available at: http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/Multiple-Myeloma/ Accessed August 2017.

^[6] Moreau P, Richardson PG, Cavo M, et al. Proteasome Inhibitors in Multiple Myeloma: 10 Years Later. Blood. 2012; 120(5):947-959.

^[7] Kyprolis® (carfilzomib). Summary of Product Characteristics. December 20, 2016. Available at https://www.medicines.org.uk/emc/medicine/31222 . Accessed August 2017.