Celgene’s multiple myeloma pill launched in UK
pharmafile | August 15, 2013 | News story | Sales and Marketing | Celgene, Velcade, low, myeloma
Celgene’s new oral blood cancer drug pomalidomide has been launched in the UK and Ireland as a third line treatment for multiple myeloma.
The drug, which has the planned brand name Imnovid, is approved for use in combination with steroid treatment dexamethasone for adults with relapsed and refractory multiple myeloma (rrMM).
It is specifically licensed for those who have received at least two prior therapies, including Celgene’s established myeloma treatment Revlimid (lenalidomide) and Millennium/Takeda’s Velcade (bortezomib), and have also demonstrated disease progression while on their last therapy.
The authorisation is based on results from the Phase III MM-003 study, which demonstrated significant advantages for pomalidomide in progression-free survival and overall survival when compared to high dose dexamethasone alone.
“This decision represents a significant milestone for people with multiple myeloma,” said Professor Steve Schey, lead investigator for the MM-003 study and consultant haematologist at King’s College Hospital, London.
“These patients have exhausted multiple therapies, including current standards of care. The introduction of pomalidomide gives these patients another option and can potentially help extend remissions in this incurable disease.”
Multiple myeloma is the second most common blood cancer and affects an estimated 9,900 people in the UK and Ireland.
The disease causes plasma cells to replicate uncontrollably and accumulate in the bone marrow, disrupting the production of normal blood cells. Nearly all individuals diagnosed with multiple myeloma will eventually relapse and require treatment with an alternative therapy.
For this reason, Celgene says it is “crucial that new and effective options continue to be made available to them to enable continued disease control”.
Charity welcomes decision
Myeloma UK’s chief executive, Eric Low said, “This decision by the European Commission to approve the use of pomalidomide across Europe is fantastic news. It means that there is now a treatment option available for patients in the relapsed and refractory setting, previously a major area of unmet need.
“Whilst this 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.”
He added: “Myeloma UK will be doing everything we can and collaborating with all stakeholders to ensure that the myeloma community in the UK is able to benefit swiftly from today’s decision.”
Whilst not yet approved by NICE, pomalidomide is currently available to UK myeloma patients through the STRATUS study which is looking at pomalidomide in combination with low-dose dexamethasone.
NICE will most likely be looking at the drug later this year and aim to make a final decision on whether the NHS can fund it by early 2014.
Myeloma UK said it would soon be launching a pomalidomide trial that will provide access to pomalidomide for 250 relapsed and refractory myeloma patients in the UK.
Part of the innovative Myeloma UK Clinical Trial Network, the trial will be looking at combinations of pomalidomide and dexamethasone.
Ben Adams
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