The drug, made by Coherus BioSciences, had initially been granted priority review as a breakthrough therapy that met FDA criteria for expedited review of drugs for serious conditions.
The drug was approved in combination with cisplatin and gemcitabine as a first-line treatment for adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma. Toripalimab-tpzi itself was also approved by the FDA “as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.”
In clinical trials, toripalimab-tpzi — also called Loqtorzi — showed a “statistically significant progression-free survival” rate of 11.7 months compared to just eight months without. Adverse reactions as both a first-line treatment and a single agent therapy were seen in less than 20% of patients in the trial.
The approval of the cancer drug comes as a nationwide cancer pharmaceutical shortage has just begun to ease.
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