FDA Approves Drug for Unresectable or Metastatic Uveal Melanoma
The U.S. Food and Drug Administration (FDA) approved a novel drug on January 25, 2022, to treat certain patients with metastatic uveal melanoma, a rare cancer of the eye.
The FDA approved KIMMTRAK® (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function.
Bahija Jallal, CEO of Immunocore, said in a press release issued on January 26, 2022, "Every year in the U.S., hundreds of people are diagnosed with mUM who, until now, had no approved treatment options."
Uveal melanoma is a rare and aggressive form of melanoma that affects the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease.
"KIMMTRAK is the first therapy to demonstrate a survival benefit to patients with this disease, and we are focused on making KIMMTRAK available as quickly as possible."
"We're also proud to have developed the world's first approved TCR therapeutic, which we believe validates the strength of our platform and opens doors for us to explore further breakthrough discoveries in TCR therapeutics for the treatment of other cancers and diseases with high unmet need," added Dr. Jallal.
This FDA review used the Real-Time Oncology Review pilot program, which streamlined data submission before filing the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA's assessment.
This application had been granted priority review, breakthrough designation, and orphan drug designation.
The company is ready to commercialize KIMMTRAK and expects to make the product commercially available in the U.S. within weeks.