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  • Rolling submission for Tuoyi to FDA completed for ...

Rolling submission for Tuoyi to FDA completed for nasopharyngeal carcinoma.- Shanghai Junshi Biosciences/Coherus Biosciences

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Published:3rd Sep 2021
Shanghai Junshi Biosciences and Coherus Biosciences announced the completion of the rolling submission of the Biologics License Application to the FDA for Tuoyi (toripalimab) in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

The FDA recently granted Breakthrough Therapy Designation for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for 1st line treatment of recurrent, locally advanced or primary metastatic non-keratinizing nasopharyngeal carcinoma and earlier in 2020 granted BTD for toripalimab monotherapy for patients with recurrent or metastatic non-keratinizing NPC with disease progression on or after platinum-containing chemotherapy. BTD is intended to expedite the development and regulatory review of drugs where preliminary clinical evidence demonstrates substantial improvement over existing therapies for a severe or life-threating disease.

The submission is supported by the results from “POLARIS-02” and “JUPITER-02”. The POLARIS-02 study is a multi-center, open-label, pivotal Phase II clinical study, results of which were published online in January 2021 in Journal of Clinical Oncology. The JUPITER-02 study is a randomized, double blind, placebo-controlled pivotal Phase III clinical trial, results of which were recently presented at the ASCO plenary session (#LBA2) and published in the August 2021 on-line edition of Nature Medicine.

Condition: Nasopharyngeal Carcinoma
Type: drug

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