text_1: Immunotherapy Drug Becomes First Therapy Approved by FDA for Rare Skin Cancer
text_2: A new drug approval offers an opportunity to review the evidence with readers. This news release from the Fred Hutchinson Cancer Research Center about a newly approved drug for Merkel cell carcinoma (MCC), a rare type of skin cancer, missed that chance. We understand the need to get the news out there and even to highlight a patient story, but there is enough evidence on benefits and risks associated with immunotherapy, not to mention costs, that news releases should give readers a fuller picture. Without that important information, the dramatic experience of the cancer patient in the release provides an overly optimistic picture of patient outcomes for everyone who may be diagnosed with this particular type of cancer. MCC is a rare, often aggressive type of skin cancer, with about 1,500 new cases diagnosed in the U.S. each year. The 5-year survival rate for MCC is estimated at around 60 percent, according to MayoClinic.org. This is the first drug approved for treating MCC — but not the only recognized treatment for the disease. Some of the media interest in the approval relates to the rapidity with which the FDA approved it while awarding the drug several special designations — accelerated approval, priority review, breakthrough therapy and orphan drug status, the latter of which “provides incentives to assist and encourage the development of drugs for rare diseases,” according to the FDA’s news release on the approval. Readers should keep in mind that the evidence for the drug is limited and based on a small study of short duration.