FDA approves first oral proteasome inhibitor for multiple myeloma
Source: Nephron / Wikimedia Commons
A new combination therapy for patients with multiple myeloma whose previous treatment has failed has been approved by the US Food and Drug Administration (FDA).
The FDA has given the go-ahead to ixazomib (Ninlaro) — the first oral proteasome inhibitor — which blocks enzymes from multiple myeloma cells, hindering their ability to grow and survive. It is approved for use in combination with lenalidomide (Revlimid) and the corticosteroid dexamethasone.
The FDA’s decision was based on the results of an international, randomised, double-blind clinical trial involving 722 patients whose multiple myeloma either returned or failed to respond to previous treatment.
Patients were given ixazomib in combination with lenalidomide and dexamethasone or placebo plus lenalidomide and dexamethasone. Those taking ixazomib lived an average 20.6 months longer without their disease worsening compared with patients taking the other regimen whose average survival was 14.7 months.
Ixazomib — which has orphan drug status — was given priority review by the FDA. Priority review status is granted if a drug would be a significant improvement in safety or effectiveness in the treatment of a serious condition.
The announcement about ixazomib follows the approval of another multiple myeloma treatment — daratumumab (Darzalex) — by the FDA on 16 November 2015. The drug is the first monoclonal antibody for patients with the disease and is used to treat patients who have failed to benefit from at least three previous treatments.
Daratumumab was granted orphan drug status in the European Union by the European Medicines Agency in 2013.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20200144
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