FDA approves UNLOXCYT, Checkpoint Therapeutics' PD-L1 blocking antibody for advanced cSCC patients.
From GlobeNewswire: 2024-12-13 18:15:14
Checkpoint Therapeutics has received FDA approval for UNLOXCYT, the first PD-L1 blocking antibody for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma in adults. The recommended dosage is 1,200 mg administered every three weeks. This approval marks Checkpoint’s entry into the commercial market, with an estimated annual U.S. market value exceeding $1 billion. The drug has shown clinically meaningful objective response rates, providing a new immunotherapy option for cSCC patients. UNLOXCYT blocks PD-L1, releasing inhibitory effects and inducing antibody-dependent cell-mediated cytotoxicity.
cSCC is the second most common skin cancer in the U.S., with approximately 1.8 million cases annually. While most cases are curable, around 40,000 cases advance each year, leading to an estimated 15,000 deaths. UNLOXCYT offers a new treatment option for patients with advanced cSCC, with the ability to induce durable responses. The drug’s dual mechanisms of action and safety profile make it a promising option for oncologists treating cSCC patients. UNLOXCYT approval was granted based on data from a multicenter study showing significant response rates and response duration.
UNLOXCYT is a PD-L1 blocking antibody that releases inhibitory effects on the anti-tumor immune response, providing a new treatment option for patients with cSCC. However, the drug can cause severe immune-mediated adverse reactions affecting various organs and tissues. These reactions may manifest during or after treatment, requiring close monitoring and prompt medical management. UNLOXCYT can also cause infusion-related reactions and complications in patients undergoing stem cell transplantation. Pregnant women should be advised of the potential risks of fetal harm when taking UNLOXCYT. Common adverse reactions to the drug include fatigue, musculoskeletal pain, rash, and diarrhea.
Read more at GlobeNewswire: Checkpoint Therapeutics Announces FDA Approval of