Update on Drugs and Drug News

Update on Drugs and Drug News: January-February 2016

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STL Volume 21 Number 1

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January 1, 2016

Name/Company	Approval Dates and Comments
Autologous cell suspension ReCell^® ReGenerCell^® ReNovaCell^® Avita Medical	CE Mark authorization for Europe was granted in October 2015 to this autologous cell suspension technology for various wound healing applications. The approval follows and expands the previous approval of ReCell^®, a medical device for treating burns. Under the new CE Mark, ReCell^® will remain focused on acute wounds such as burns. A new presentation, ReGenerCell^®, will target chronic wounds, such as venous leg ulcers and diabetic foot ulcers. And a third presentation, ReNovaCell^®, will be aimed at the aesthetic applications, and will cover conditions linked to pigmentation and scar revision.
Calcipotriene 0.005% + betamethasone dipropionate 0.064% foam Enstilar^® 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.
Ipilimumab Yervoy^® Bristol-Myers Squibb	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 Imlygic™ BioVex/Amgen	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.
Cobimetinib + vemurafenib Cotellic™ + Zelboraf^® Daiichi Sankyo Exelixis Genetech/Roche	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^® Novartis AG	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.
Nivolumab injection Opdivo^® Bristol-Myers Squibb	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).