The European licence for daratumumab (also known as Darzalex) is to be extended for use in combination with other myeloma drugs for the treatment of relapsed patients who have had at least one prior therapy.
Currently daratumumab is licensed for use in Europe on its own, which is known as a monotherapy.
The Committee for Human Medicinal Products (CHMP) has now recommended that the European Medicines Agency, which is Europe’s licensing body, extend the licence. This would allow daratumumab to be used in combination with lenalidomide (Revlimid®) and dexamethasone, or bortezomib (Velcade®) and dexamethasone.
Daratumumab belongs to a group of immunotherapy treatments known as monoclonal antibodies. You can find out more by reading the Myeloma UK Daratumumab Infosheet.
Myeloma UK Policy and Public Affairs Manager, Kate Morgan said, “This is good news for patients. Daratumumab is an innovative treatment which has delivered good results in clinical trials when used in combination.
“However, there is still a lot of work to be done in seeking access to these treatments in the NHS – particularly given issues around the cost-effectiveness of three drug combinations. We believe strongly that patients in the UK must have access to the best possible new myeloma drugs and we will work collaboratively with Janssen, who hold the licence for daratumumab, and the UK drug approval bodies to make this important new treatment option available.”
The extension of the licence is based on evidence from the CASTOR and POLLUX Phase III trials. The CASTOR trial showed that patients receiving daratumumab in combination with bortezomib and dexamethasone had a 61% reduction in their disease progressing compared to those who received bortezomib and dexamethasone alone.
In the POLLUX trial, patients who received daratumumab with lenalidomide and dexamethasone recorded a 63% reduction in risk of their myeloma progressing compared to those who received lenalidomide and dexamethasone alone. More information on the trials can be found here.
What are the next steps for access?
The recommendation has now been passed to the European Commission which has 60 days to issue final guidance on whether the licence should be extended. It is very rare for the Commission to go against a CHMP recommendation.
Once approved it must be assessed by the drug approval body for England and Wales, the National Institute for Health and Care Excellence (NICE) and the drug approval body in Scotland, the Scottish Medicines Consortium. The timings for the assessment of daratumumab combinations have yet to be confirmed.
Kate continued, “There may be challenges in securing approval for daratumumab in combination with other treatments, partly because there are now more effective myeloma drugs available than ever before. This makes it harder to prove that new treatments are cost-effective compared to the current standard of care. Myeloma UK will work with the company, leading doctors and the drug approval bodies to make the strongest case possible for approval to be granted.”
For practical advice and support call the Myeloma Infoline on 0800 980 3332 or email AskTheNurse@myeloma.org.uk.
For more information on the drug approval process contact firstname.lastname@example.org.