[Beacon Staff]

Revlimid recommended for frontline approval in Europe

by Beacon Staff on Fri Dec 19, 2014 4:32 pm

Hello everyone,

Celgene announced earlier today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended that Revlimid be approved in Europe for use in adult patients with previously untreated multiple myeloma who are not eligible for stem cell trans­plan­ta­tion.

This is only a recommendation, but CHMP's recommendations are almost always eventually approved, generally within about two months.

If the Committee's recommendation is approved, it would permit many more patients in Europe to be treated with Revlimid as part of their first treatment regimen than has been the case thus far. Restrictions on "off-label" prescribing – that is, not officially approved prescribing – in much of Europe have meant that, until now, Revlimid has been used primarily as a treatment for relapsed myeloma in much of the region.

Revlimid is not officially approved for use as a first-line treatment in Europe or, for that matter, in the U.S. However, there are far fewer restrictions on off-label prescribing in the U.S. compared to other countries, such that Revlimid is a common first-line treatment in the U.S., generally in combination with dexamethasone and, in many cases, Velcade.

Note, however, that the European Committee's recommendation is for Revlimid to be approved as a potential first-line treatment in newly diagnosed patients who are NOT transplant eligible. This will limit its potential use as initial therapy in Europe to patients who are over the age of 65.

Note, as well, that eventual European approval of the new use for Revlimid will not automatically mean it will be reimbursed for the new use in all of Europe. In the UK, for example, additional deliberations will be necessary for health authorities to approve spending on Revlimid for newly diagnosed patients.

Celgene also is seeking official U.S. approval for Revlimid to be used in newly diagnosed patients. A decision on that application is expected by the end of February.

The full Celgene press release announcing the European advisory Committee's recommendation can be viewed at The Beacon here:

"Celgene Receives Positive CHMP Opinion To Extend Revlimid (Lenalidomide) For Continuous Use In Patients With Newly Diagnosed Multiple Myeloma And Ineligible For Transplant," Celgene Press Release issued Dec 19, 2014.