As expected, Celgene has been given the thumbs-up in Europe for its myeloma drug pomalidomide, which will be marketed as Imnovid.
Specifically, the European Commission has granted approval for pomalidomide in combination with dexamethasone, for the treatment of relapsed and refractory multiple myeloma. It can be given to adults who have received at least two prior therapies including both Celgene's own Revlimid (lenalidomide) and Johnson & Johnson/Takeda's Velcade (bortezomib) and have demonstrated disease progression on the last drug taken.
The approval is based on the Phase III 455-patient MM-003 study which demonstrated significantly improved median progression-free survival of 15.7 weeks for patients with rrMM who were treated with pomalidomide plus low-dose dexamethasone, compared with 8.0 weeks for those on high-dose dexamethasone only. Median overall survival was also significantly improved with the new drug and the decision follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use in May.
Xavier Leleu of the Hopital Claude Huriez in Lille, France, an investigator on the MM_003 trial, noted that most patients diagnosed with MM will relapse at some point "and I have seen many patients who have become refractory to a number of treatments. The urgency now is to develop novel agents that help those patients who have tried several therapies and exhausted current standards of care". He added that the approval of pomalidomide "is great news and a major step forward for these patients across Europe who need a new effective treatment option to help manage their disease".
Alan Colowick, president of Celgene Europe, the Middle East and Africa, said that his is "one of the few companies to deliver treatments across all stages of MM, right from the start at diagnosis through to the support that pomalidomide can now offer late-stage MM patients who have exhausted other treatment options".
[UPDATE] Myeloma UK chief executive, Eric Low said that while the approval "is fantastic news, there is still a lot of work to be done to ensure that pomalidomide is made available to patients in the UK by the relevant health technology assessment bodies". The charity also announced that it will soon be launching a trial that will provide access to pomalidomide for 250 rrMM patients in the UK looking at combinations of the drug and dexamethasone.
The drug was approved in the USA as Pomalyst in February.