Posted on 8.17.11 at 1:48 pm. No Comments.
The FDA announced the approval of Zelboraf, an exciting breakthrough for patients with metastatic melanoma. Melanoma remains one of the most deadly and difficult to treat cancers. Once it gets out of the skin, traditional chemotherapies despite having severe side effects, do very little. Over 7,000 patients a year die of melanoma and rates are increasing at an alarming rate. A few months ago, a medication was approved called Yervoy that stimulated the patient’s own immune system to help fight the cancer. This medication is very expensive ($120,000 per treatment) and not very effective, only increasing life span by a few months. And by stimulating the immune system, it caused a number of severe auto-immune related side effects.
Studies with Zelboraf show it to a much more efficacious medication. But there is a drawback. It won’t work for every patient. Zelboraf works by blocking a mutated protein called BRAF that promotes tumor growth. It is mutated in about 2/3 of all melanomas. Dermatologists can now have a melanoma tested to see if the defective gene is present. For patients with abnormal BRAF, Zelboraf will quickly become the standard of care. Unfortunately for the 1/3 of patients with normal BRAF, there remain few options.
A six month course of Zelboraf will cost about $56,000. That price sounds astronomically high, and it is, but is about half the cost of Yervoy.
While Zelboraf slowed the progression of melanoma for months, in most patients the cancer eventually finds a way around the blockage of BRAF. At this point patients find their tumors begin to grow again. Most melanoma have several genetic defects in addition to BRAF. Future treatments that might one day hope to cure melanomas would need to block multiple defects instead of just one. This would be much more difficult for the tumors to get around. Unfortunately it would also be very expensive. Roche the makers of Zelboraf and Bristol-Myers the makers of Yervoy have agreed on a combined study to see if the combination of both drugs would be better than either alone. Drug companies do not often cooperate, so both Roche and Bristol-Myers should be commended for partaking in a study that could really benefit patients.