Please login to the form below

Not currently logged in
Email:
Password:

Merck melanoma drug approved

The US Food and Drug Administration has granted marketing approval to Merck's Sylatron (peginterferon alfa-2b) melanoma treatment

The US Food and Drug Administration (FDA) has granted marketing approval to Merck's Sylatron (peginterferon alfa-2b) melanoma treatment.

The drug, which is injected subcutaneously, is indicated for the adjuvant treatment of node-positive melanoma. Specifically, it has been cleared for use within 84 days of definitive surgical resection including complete lymphadenectomy for the treatment of melanoma with microscopic or gross nodal involvement. Patients can self-inject the drug once a week, Merck noted.

The approval was based on a single, open-label trial of 1,256 patients who had had surgery and were randomised to receive either Sylatron or observation for five years.

The primary efficacy endpoint was relapse-free survival, which had an estimated median time of 34.8 months in the treatment group and 25.5 months in the observation-only group. There was no difference in overall survival between the Sylatron and the observation arms.

The drug was developed by Schering-Plough and became part of Merck's pipeline when the two companies merged.

Sylatron is the second significant new drug for melanoma to win FDA approval in recent weeks. Last month, the FDA approved Bristol-Myers Squibb's Yervoy (ipilimumab) for the treatment of unresectable or metastatic melanoma, noting that the therapy demonstrates a 'significant improvement' in overall survival for patients whose skin cancer cannot be treated with surgery or has spread to other organs.

12th April 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Lucid Group Communications Limited

WE’RE ON A MISSION To enhance patients’ lives through communication that changes behaviour and improves patient health outcomes....

Latest intelligence

patients
Retaining reader value in plain language summaries of clinical studies
Balancing the risk of misinterpretation with the public’s ability to understand simplified plain-language summaries...
Can we talk about the ego-bias and chemicals influencing your target audience’s behaviour?
Over the Summer, the Page & Page team became fascinated by two books on this very subject. Two books from one author, Dean Burnett, an eminent neuroscientist, lecturing at Cardiff...
Paris
Making Europe a leader in bioscience: boosting trust and opening minds
A vision of Paris as Europe's leading hub for life sciences innovation...

Infographics