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Pomalidomide (Pomalidomide Celgene®) has been granted a licence for use in myeloma patients across Europe.
This decision by the European Commission follows the positive recommendation in May 2013 for pomalidomide by the Committee for Medicinal Products for Human Use (CHMP), within the European Medicines Agency (EMA).
MPE Vice-Chair, Eric Low said that “today’s 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 countries across Europe.
Pomalidomide is a promising new drug in the treatment of relapsed and refractory myeloma. It was granted approval by the United States Food and Drug Administration (FDA) earlier this year on the back of positive Phase III clinical trial data.
The licence application to the European equivalent of the FDA – the European Medicines Agency (EMA) – was based on data from a large Phase III clinical trial called the MM-003 trial.
This study involved 455 patients and compared the effectiveness of pomalidomide in combination with low-dose dexamethasone to high-dose dexamethasone alone, in relapsed and refractory myeloma patients who had previously been treated with both Revlimid® and Velcade®.
The results of the study showed that pomalidomide in combination with low-dose dexamethasone significantly improved the time patients remained myeloma free (in remission or plateau) and gave an overall advantage in terms of extending patients’ lives compared to high-dose dexamethasone.
The results of this trial were presented at ASH 2012.
The potential benefits of pomalidomide

Pomalidomide is an immunomodulatory drug (IMiD) that has a similar mechanisms of action to thalidomide and Revlimid® – both are commonly used as anti-myeloma treatments.
However, data from a number of different studies show that pomalidomide is more potent than thalidomide and Revlimid® and is effective even in relapsed and refractory patients who no longer respond to thalidomide, Revlimid® or Velcade®. The approval of pomalidomide is therefore very promising for this group of patients.
The MM-003 trial also found that pomalidomide is associated with a better side-effect profile with fewer incidences of thrombocytopenia (low platelet count) and peripheral neuropathy than with Revlimid® and thalidomide.
There was however a higher incidence of neutropenia (low white blood cell count) in patients receiving pomalidomide compared to those receiving high-dose dexamethasone. The levels of neutropenia were comparable to the levels seen with Revlimid®.
You can see the full press release of 9 August 2013 here.

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