In the United States, Fast Track is the process designed to facilitate the development, and speed up the review, of therapies designed to fill an unmet need or treat serious conditions in some way. A drug that receives Fast Track designation becomes eligible for more frequent FDA meetings, Priority Review and Accelerated Approval eligibility, Rolling Review, and more. According to an article in the Dermatology Times, the FDA recently granted Fast Track designation to ITI-3000 for patients with Merkel cell carcinoma.
ITI-3000 is a plasmid DNA vaccine which uses the PharmaJet Stratis Needle-Free Injection System. The therapy is administered intramuscularly. Currently, Immunomic Therapeutics, the developer of ITI-3000, is enrolling patients within a Phase 1 clinical study to further evaluate this therapy with this injection system.
What is Merkel Cell Carcinoma (MCC)?
Merkel cell carcinoma is a rare form of skin cancer which usually occurs as a reddish or flesh-colored nodule. These most often appear on the head, neck, or face. Although this cancer is aggressive – with many people experiencing recurrence within 2-3 years following when someone is originally diagnosed – it is treatable, especially in early stages. MCC may also be known as neuroendocrine carcinoma of the skin. There are a number of risk factors associated with Merkel cell carcinoma, such as having fair skin, being over 50 years old, a history of skin cancer, or having a weakened immune system. The Merkel cell polyomavirus has also been implicated.
Symptoms and characteristics related to this cancer can include a fast-growing, painless nodule on the skin that could be purple, red, blue, or flesh colored. This nodule may bleed easily or crust over. The Skin Cancer Foundation shares that up to 56% of MCCs are thought to be benign at first and are often misdiagnosed as infected hair follicles or cysts.
Therapeutic options for those with Merkel cell carcinoma include radiation therapy, immunotherapy, chemotherapy, and surgery to remove the nodules.
