| Name/Company | Approval Dates/Comments |
| Pembrolizumab for IV injection Keytruda® Merck & Co. |
In December 2018, the US FDA approved an expanded label for the checkpoint inhibitor, pembrolizumab. The additional indication for this anti-PD-1 (programmed cell death protein-1) therapy includes the treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Approval was based on results from the Cancer Immunotherapy Trials Network (CITN)’s CITN-09/KEYNOTE-017 clinical trial. In this Phase 2 trial of 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease, pembrolizumab monotherapy demonstrated an objective response rate of 56% (95% CI, 41-70), with a complete response rate of 24% (95% CI, 13-38) and a partial response rate of 32% (95% CI, 20-47). |
| Oral JAK + SYK dual inhibitor ASN002 Asana Biosciences |
The FDA granted Fast Track designation in December 2018 to ASN002, an investigational oral Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK) dual inhibitor for the treatment of moderate-to-severe atopic dermatitis (AD). ASN002 is currently being evaluated in moderate-to-severe AD in the Phase 2b RADIANT Study (Relief from Atopic DermatitIs with JAK and SYK INhibiTion, NCT03654755). It is also being studied in a Phase 2 trial in patients with severe chronic hand eczema (NCT03728504). ASN002 is the first oral drug to demonstrate improvement in AD lesional skin phenotype associated with clinical efficacy. |
| Lidocaine 7% + tetracaine 7% local anesthetic cream Pliaglis® Crescita Therapeutics Taro Pharmaceuticals |
In December 2018, the FDA approved removal of the “Not for Home Use” label restriction for this topical anesthetic cream with the addition of a new user instruction sheet and product applicator. Pliaglis® is a combination of lidocaine and tetracaine indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal. This product utilizes a proprietary phase-changing topical cream “Peel” technology. The “Peel” technology consists of a drug containing cream which, once applied to a patient’s skin, dries to form a pliable membrane that releases drug into the skin. After 20-30 minutes, the layer is peeled away, leaving the skin sufficiently anesthetized. |
| PrabotulinumtoxinAxvfs for IM injection Jeuveau™ Evolus, Inc. |
The FDA approved the first aesthetic-only injectable neurotoxin in February 2019 for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults. PrabotulinumtoxinA-xvfs is a proprietary 900 kDa purified botulinum toxin type A formulation. FDA approval was granted to Jeuveau™ on the basis of the TRANSPARENCY clinical program that involved the study of over 2,100 patients globally, which included two US pivotal Phase 3 trials and a European & Canadian Phase 3 head-to-head trial versus Botox®. PrabotulinumtoxinA-xvfs met both the primary and secondary endpoints in all of the completed studies with no serious drug-related adverse events reported. |
