The treatment is the first anti-PD-1 antibody from China to receive Breakthrough therapy designation.
FDA granted Breakthrough Therapy Designation to Toripalimab (Junshi Biosciences) to treat nasopharyngeal carcinoma. The drug is the first anti-PD-1 antibody from China to receive BTD, according to Junshi.
“The Breakthrough Therapy designation granted by FDA recognizes the significant clinical benefits Toripalimab has shown for the treatment of nasopharyngeal carcinoma,” said Ning Li, MD, CEO of Junshi Biosciences, in a press release.
“Junshi prioritizes cancer types with high prevalence in China such as nasopharyngeal carcinoma, lung and liver cancer, but we found that great unmet medical needs also exist in other countries where patients are endangered by this deadly disease,” Li said. “The BTD will allow us to work with the FDA closely to bring the therapy to patients worldwide expeditiously.”
However, Junshi did not say when the drug would be available in the U.S.
The anti-PD-1 monoclonal antibody received its first approval for second-line treatment of metastatic melanoma in China in 2018.
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In March, FDA granted Toripalimab in combination with axitinib in the treatment of mucosal melanoma orphan drug designation. And in May, the treatment was granted orphan drug designation by FDA to treat nasopharyngeal carcinoma.
The company has carried out more than 30 clinical studies covering more than 10 indications for the treatment.