Two medications are approved in the US to treat advanced melanoma. Zelboraf (vemurafenib) was approved in September, 2012. DTIC-Dome (dacarbazine) is used to treat Hodgkin's lymphoma as well as melanoma. Which is the better medication?
The German Health Care System and the Federal Joint Committee (G-BA) is like our US Food and Drug Administration. Its scientists have studied and examined both vemurafenib and dacarbazine.
Their evaluation found that Zelboraf helped advanced melanoma patients live longer than DTIC-Dome did. And while the side effects were “major,” the researchers concluded that vemurafenib “offers considerable overall benefit” for patients with advanced melanoma.
Melanoma is a potentially deadly form of skin cancer. It is cancer of the skin cells that produce dark pigment – the melanin. Melanoma is diagnosed in just over 76,000 Americans every year.
This study was done to complete a regulatory requirement in Germany called the Act on the Reform of the Market for Medicinal Products (AMNOG). It was carried out by the German Institute for Quality and Efficiency in Health Care (IQWiG), which conducts benefit and cost analyses and serves as an advisor to the G-BA.
The purpose was to describe the “added benefits” vemurafenib offered over dacarbazine in patients whose inoperable melanoma had spread (metastasized). These patients each had a mutation in the BRAF V600 gene.
A total of 675 patients were randomly assigned to receive either vemurafenib or dacarbazine. Both the patients and their doctors knew which drug they were taking. The study looked at overall survival, complications, impact on quality of life and adverse events associated with each drug.
Half of the people taking dacarbazine were still alive after 10 months. For those taking vemurafenib, half of the people were alive after more than 13 months.
Members from both groups complained similarly of pain as the primary complication of the therapy, and they judged their physical and emotional well-being to be about the same.
In terms of severe and serious side effects, though, the IQWiG found vemurafenib to be inferior to dacabazine. Major adverse events (complications) were more frequent and severe among those taking vemurafenib.
So the IQWiG saw that the benefits of vemurafenib were major, but so were its harms.
The study was published by IQWiG Reports.