This is interesting on the approval as it is based on data from Europe and not here, but if it works, that’s good enough. Not too long ago the FDA used information from a clinical trial in China for approval of a drug, and the company also had a US counterpart office. Perhaps things are moving a bit faster at the FDA with using studies and documentation from outside the country. The injection is to be used after the removal or a surgical procedure. BD
(Reuters) - Merck & Co Inc said the U.S. health regulator approved its drug to treat skin cancer in patients with node-positive melanoma, following removal of the affected part.
Merck's drug Sylatron, which is delivered by a subcutaneous injection, is indicated as an additional treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection.
The company said patients with a history of severe allergic reaction to hepatitis C drugs peginterferon alfa-2b or interferon alfa-2b should not use Sylatron.
Merck said the approval of the drug is based on data from the European Organization for the Research and Treatment of Cancer.