EU regulators have expanded the scope of Janssen’s Darzalex to include patients with multiple myeloma who have received at least one prior therapy, when given in combination with lenalidomide and dexamethasone, or bortezomib (Velcade).
The initial marketing authorisation was granted in May 2016 for Darzalex (daratumumab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last treatment.
This was cleared under conditional approval but has now been converted into a full green light on the back of new clinical data submitted by the firm.
The decision to expand the drug’s approval was based on findings of the Phase III Pollux and Castor trials, which showed that the addition of Darzalex significantly reduced the risk of disease progression or death - by 63 percent and 61 percent, respectively - when combined with standard of care regimens.
“These results show daratumumab in combination with either a proteasome inhibitor or an immunomodulatory agent has the potential to provide clinical benefit to patients after one or more lines of therapy,” said Torben Plesner, Vejle Hospital, Vejle, Denmark, an investigator on trials of the drug.
“We are encouraged by the data we have seen for daratumumab to date and will continue to investigate its potential,” added Dr Catherine Taylor, haematology therapeutic area lead, Janssen Europe, Middle East and Africa (EMEA).
In the UK, however, access to the drug on the NHS is currently looking uncertain. Earlier this year, both the National Institute for Health and Care Excellence and the Scottish Medicines Consortium rejected funding for the drug in its primary indication.
Whilst the need for effective, well-tolerated treatment for people with the disease who have had previous therapies was recognised, preliminary guidelines from NICE noted that the clinical effectiveness of the drug could not be fully interpreted on the evidence that was presented.
This high degree of uncertainty for clinical effectiveness meant that Darzalex’ cost effectiveness results were unreliable and a most plausible ICER (incremental cost effectiveness ratio) could not be identified, it said.