|Name/Company||Approval Dates and Comments|
CE Mark authorization for Europe was granted in October 2015
LEO Pharma Inc.
In October 2015, the US FDA approved a foam containing a fixed combination of calcipotriene and betamethasone dipropionate for the topical treatment of plaque psoriasis in adults 18 years of age and older. This once daily, alcohol-free foam formulation in a pressurized spray allows application across large body areas of plaque psoriasis. Treatment is applied once daily for up to 4 weeks.
The FDA approved this immune checkpoint inhibitor in October 2015 for the additional indication of adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of >1 mm (Stage III) who have undergone complete resection including total lymphadenectomy.
Talimogene laherparepvec (T-Vec) oncolytic virus therapy
The FDA approved the first viral-based cancer therapeutic in October 2015 for the treatment of melanoma lesions in the skin and lymph nodes that cannot be removed completely by surgery. Imlygic™ is an engineered version of the herpes virus (derived from HSV-1). The virus has been modified to replicate within tumors and to produce the immune stimulatory protein human GM-CSF, which promotes a systemic anti-tumor immune response and an effector T-cell response. The agent is injected directly into the melanoma lesions.
Cotellic™ + Zelboraf®
In November, both the US FDA and EU’s European Commission (EC) approved cobimetinib (MEK-inhibitor) for use in combination with vemurafenib (BRAF-inhibitor) as an oral treatment for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. Cobimetinib works by blocking the activity of the MEK enzyme, which is part of a larger signaling pathway, thereby preventing or slowing cancer cell growth. Vemurafenib is a BRAF inhibitor that affects a different part of the same pathway and was approved in 2011 to treat patients with melanoma that has metastasized or cannot be surgically removed.
Dabrafenib + trametinib
Tafinlar® + Mekinist®
In November 2016, the FDA granted regular approval for combination therapy with dabrafenib (Tafinlar®) + trametinib (Mekinist®) to treat patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test. This is the first targeted therapy combination demonstrating more than 2 years overall survival.
In November 2015, the FDA approved nivolumab (PD-1 inhibitor) injection for IV use, as a single agent for the treatment of patients with BRAF V600 wild-type (WT) unresectable or metastatic melanoma. The approval is based on data from the Phase 3 trial, CheckMate -066, which evaluated overall survival as the primary endpoint in treatment-naÃ¯ve patients with BRAF WT unresectable or metastatic melanoma compared to chemotherapy (dacarbazine).