FDA Approves Two Immunotherapies for Advanced Melanoma

Metastatic melanoma patients have received very good news with the FDA’s approval of two important new immune-boosting therapies.

On Tuesday, October 27, 2015, the FDA approved Imlygic (talimogene laherparepvec, or T-VEC), the first-ever approved oncolytic virus therapy for melanoma. The therapy is used to treat Stage III and IV patients after surgery who have recurring lesions in the skin and lymph nodes that cannot be completely removed by surgery. An oncolytic virus is a virus that specifically targets, infects, and kills cancer cells. Imlygic is a version of the herpes simplex virus that has been genetically modified to select cancer cells but not healthy cells for infection, while also secreting granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-boosting protein that can strengthen the body’s immune response against melanoma.  In clinical trials, the therapy was shown to increase durable response rates for patients with advanced disease.

On Wednesday, October 28, 2015, the FDA approved use of Yervoy (ipilimumab) as an adjuvant therapy (a therapy that enhances initial treatment) for high-risk patients with Stage III melanoma, to lower the risk that the disease will recur or advance after lymph node surgery. Ipilimumab was approved in 2011 only for patients with Stage IV melanoma; the hope is that it will now have even greater benefits for patients whose disease is less advanced, preventing or delaying disease recurrence and progression. Median progression-free survival after three years was 46.5 percent for patients on ipilimumab, compared to 34.8 percent for patients receiving a placebo.

Published on October 29, 2015