The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's (BMS) Yervoy (ipilimumab) for the treatment of unresectable or metastatic melanoma.
The drug is the first approved therapy in the US that demonstrates a 'significant improvement' in overall survival for patients whose skin cancer cannot be treated with surgery or has spread to other organs.
The decision date for approval had been moved back from December 25, 2010, with the FDA determining that additional time was required to complete the review of the biologics licence application.
Yervoy recently showed positive results from a phase III study that compared the drug in combination with dacarbazine chemotherapy to the chemotherapy regimen alone.
Lamberto Andreotti, CEO, BMS said: "Today's approval of Yervoy is an example of Bristol-Myers Squibb living its mission of developing and delivering innovative medicines that address the unmet needs of patients with serious diseases."
BMS has said it expects to begin shipment of Yervoy within weeks.
A post-marketing study will also be carried out comparing the safety and efficacy of the 3mg/kg dose of the drug against an investigational 10mg/kg dose.