Daratumumab (Darzalex®) has been granted an extended licence 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.
Following a positive recommendation by the Committee for Human Medicinal Products (CHMP) in February this year, the European Commission has now granted an extended licence which will 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, “It is good news that the European Commission has now granted this extended licence for daratumumab to be used in combination with other myeloma treatments. Substantial evidence exists for the effectiveness of combination treatments in myeloma and daratumumab is an innovative new drug with great potential.
“These newly licensed combinations have delivered good results in clinical trials. However, challenges still lie ahead in making these treatments available on the NHS.
“This is partly because there are now more effective myeloma drugs available than ever before, making it harder to prove that new treatments are cost-effective compared to the current standard of care. Another issue is that it is being appraised in combination with two other drugs including another “novel” drug, lenalidomide, which impacts negatively on its cost-effectiveness.
“Myeloma UK will continue to strive for access to the best possible new myeloma drugs for patients. We will work with Janssen, who hold the licence for daratumumab, leading doctors and the drug approval bodies to make a strong case for approval.”
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 myeloma 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 progression 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?
These combinations must now 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 (SMC). Timings for assessment by NICE and the SMC have yet to be confirmed.
Call the Myeloma Infoline on 0800 980 3332 or email AskTheNurse@myeloma.org.uk for practical advice and support. For more information on the drug approval process, check our HTA Infosheet or contact email@example.com.