Myeloma drug Kyprolis launched in the UK
Amgen has launched Kyprolis in the UK, joining a growing field of rival medicines for multiple myeloma.
Kyprolis (carfilzomib) is licensed for use in combination with the standard treatment of Celgene's Revlimid (lenalidomide) and dexamethasone in patients who have received at least one prior therapy.
The drug has been on the US market for more than three years, but following EMA approval in November, Amgen is now rolling out the drug across Europe.
Data from the ASPIRE trials of Kyprolis show it gave patients an average of 8.7 months of extra time without disease progression compared to lenalidomide and dexamethasone alone, a significant improvement in progression-free survival (PFS).
Although advances in multiple myeloma treatment have been made in recent years, the haematological cancer remains incurable. The disease eventually becomes refractory and progresses again, despite treatment, which means new drugs are needed.
Myeloma UK chief executive Eric Low said: "Myeloma is a relapsing and remitting cancer and so it's extremely important that we continue to see access to new, effective treatments. To that end, we very much welcome the European approval of carfilzomib and we will work closely with Amgen and the various healthcare technology assessment bodies in the UK to ensure that patients get access as quickly as possible."
Amgen says it expects to submit data to England's cost-effectiveness watchdog NICE later in 2016. This submission will include data from the ASPIRE study, and the ENDEAVOR study, which is currently under review by the EMA. This study was a phase 3 head-to-head between Kyprolis and Janssen's Velcade (bortezomib), another major established treatment. The study showed Kyprolis combined with dexamethasone increased PFS by just under nine months compared to Velcade and dexamethasone in patients whose myeloma had relapsed at least once.
Amgen is aiming for a first-line treatment licence for Kyprolis, hinging on the results of its CLARION trial, with preliminary data expected in early 2017.
But Amgen is competing in an increasingly crowded field, with no fewer than four new multiple myeloma treatments approved last year.
Takeda's Ninlaro (ixazomib), Janssen's Darzalex (daratumumab), Novartis' HDAC inhibitor Farydak (panobinostat) and Bristol-Myers Squibb and AbbVie's Empliciti (elotuzumab) all gained US approval in 2015. Of these, only Farydak is already approved in Europe, but the rest are expected to gain clearance within the next few months.
Janssen's Darzalex is one of the most hotly tipped, with analysts predicting peak sales of around $4 billion. All the companies in the field will have to continue investment in new clinical trials to prove the value of the product, and increasingly in novel combinations in order to stand out from the crowd.
