The U.S. Food and Drug Administration today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).
Regulatory
Adjuvant Ipilimumab in Melanoma Approved by the FDA
Ipilimumab (Yervoy) in melanoma has been approved by the FDA to include adjuvant treatment of patients with stage III melanoma who are at high risk of recurrence following complete resection.
FDA approves Yervoy to reduce the risk of melanoma returning after surgery
Today the U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery.
New Melanoma Drug Uses Tumor-Busting Virus
The Food and Drug Administration approved a new drug Tuesday that uses a genetically engineered cold sore virus to bust up melanoma skin cancer tumors.
It’s the first drug of its type to get FDA approval. It’s made using a genetically engineered herpes virus — the same kind that causes cold sores — that carries an immune system compound into tumors, causing them to burst apart.
The drug, called Imlygic, doesn’t cure the patient and it has not been shown to help patients live longer, But it provides relief from melanoma, the deadliest form of skin cancer.