Please login to the form below

Not currently logged in
Email:
Password:

FDA approves BMS' skin cancer drug

The US Food and Drug Administration has approved Bristol-Myers Squibb's Yervoy for the treatment of unresectable or metastatic melanoma

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.

28th March 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Health Unlimited

Health Unlimited is a global health consultancy and communications agency built by specialists with unmatched experience, perspective and expertise. For...

Latest intelligence

OPEN Health Graduates and the XP Support Group
During our graduate induction period in September 2018, we were asked to find a charity that could benefit from the expertise of the OPEN Health practices. We made the decision...
Alexander Devine Website has gone live!
As part of the OPEN Health CSR programme one of the charities we support is Alexander Devine. They are a local Children's Hospice based in Maidenhead who provide a truly...
Drug pricing and competition
Strengthening business competition and reducing anti-competitive practices
How the CMA is tackling high prices for essential drugs...

Infographics