Important FDA drug approval for multiple myeloma patients18 Feb 2015
Positive news for multiple myeloma patients as the U.S. FDA has expanded the use of Celgene’s cancer drug, Revlimid, to include newly diagnosed patients as well. Until now, the drug was only approved for patients who had received at least one previous therapy.
The US FDA's action means that all multiple myeloma patients can potentially Revlimid, in combination with a different drug, dexamethasone.
Why is this use-expansion important for multiple myeloma patients?
- As 50% of patients with multiple myeloma are newly diagnosed, they were excluded from this treatment. The drug was approved only for the patients, who have received one or more prior therapies. Now, the drug will be available for the newly diagnosed patients as well.
- Although physicians in the United States have long been prescribing Revlimid for new patients on an "off-label" basis, the company was not allowed to promote its use in this population. In Europe, where physicians are not allowed to prescribe off-label, the situation is different. Celgene expects European regulators to approve the drug for newly-diagnosed patients within the next few weeks.
- The drug is approved in 70 countries for previously treated patients. The company hopes that approvals in the U.S. and Europe will pave the way for other countries to approve the drug for newly diagnosed patients.