This story reports on U.S. Food & Drug Administration approval of Cotellic in combination with vemurafenib to treat advanced melanoma, cancer that has spread throughout the body. The story adheres very closely to the FDA announcement and includes ample information on the side effects. However, the story does not convey the actual efficacy of this drug combination, stating only that that “The FDA said the safety and efficacy of Cotellic in combination with vemurafenib were shown in a clinical study of 495 patients.” There is no indication of how well this drug combination works and it is also not made immediately clear that this drug combination works only for one genetic varient of melanoma, the BRAF V600 mutation. We think the most egregious problem with this story is that nothing at all is said about the cost of this drug. The combination is reportedly going to be priced at $17,600 per month.
According to the FDA, melanoma is the most aggressive and dangerous form of skin cancer in the United States. The National Cancer Institute estimates that 73,870 Americans will be diagnosed with melanoma and 9,940 will die from the disease this year. The incidence of melanoma among younger people is increasing. Once melanoma has spread to other parts of the body it is very difficult to treat.
This story does not address costs at all, even though one half of the drug combination –vemurafenib — is already being used in treatment and costs $11,000 per month of treatment. The combination treatment is reportedly going to cost $17,600 per month, and it is not clear whether payers will cover it.
This story does not quantify the benefits at all except for saying that the safety and efficacy was tested on over 400 patients. What benefits they received from the treatment are totally omitted from the story. This is unacceptable, especially as the FDA provided some quantification in their news release.
This story states both the severe and mild side effects of taking this drug. We’ll rule this Satisfactory since there was a good-faith attempt to address the criterion. However, while the array of side effects are listed they are not quantified. We do not know what proportion of those taking the medication get each side effect. Nor do we know how severe they are, or how many stopped the medicine die to the side effects. More detail would have been welcome.
This story provides no evidence at all and relies on the fact that the FDA approved the drug combination. The research that led to the approval is not described in any meaningful way.
There is no disease mongering here. Advanced melanoma is a terrible disease and many treatments fail.
There appear to be no outside sources used in this story. All the information comes from the FDA. However, because of that, there is no conflict of interest as the drug manufacturer/distributor is identified, but no information apparently comes from them.
It is important to remember here that the role of the FDA is to approve based on effectiveness and safety and the bar for both in a disease like melanoma is low. How clinically useful this drug will prove to be is open to question and it would have been nice to hear from some independent oncologists about that.
No alternative therapies are discussed in the story. There is a lot of new drug development for melanoma; none mentioned.
Because this is an announcement from the FDA about approval, the drug will now be marketed for treatment, and the story clearly indicates that the drug combination is distributed by Genentech.
We’ll rule this Satisfactory, but we’d caution that FDA approval does not necessarily equal availability. The key factor here is the cost and who will pay for it, or not. The story doesn’t address this.
The news hook here is the FDA approval of this drug combination. We’ve already given the story credit for this above under “Availability.” And we’d note that just because the FDA approves something, doesn’t mean that it’s novel. There are plenty of “me-too” drugs out there, and this story doesn’t make any attempt to clarify how this new drug combination works differently or better than existing drugs.
This story appears to rely exclusively on a news release from the FDA and there are many similarities in the text of the two documents. Unfortunately, the story leaves out much of the quantitative data and other useful details included in the FDA news release.