FDA grants breakthrough therapy designation to toripalimab for nasopharyngeal carcinoma
The FDA granted breakthrough therapy designation to toripalimab in combination with chemotherapy for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, according to the agent’s manufacturer.
The agency previously granted breakthrough therapy designation to toripalimab (Shanghai Junshi Biosciences/Coherus Biosciences) as monotherapy for patients with recurrent or metastatic nasopharyngeal carcinoma whose disease progressed on or after platinum-containing chemotherapy.
Junshi Biosciences anticipates completing a biologics license application submission for both indications by the end of the third quarter.
Toripalimab is an anti-PD-1 monoclonal antibody.
The phase 3 JUPTER-02 trial evaluated toripalimab in combination with chemotherapy for first-line treatment of nasopharyngeal carcinoma.
As Healio previously reported, results presented during this year’s virtual ASCO Annual Meeting showed a statistically significant improvement in PFS with the combination compared with chemotherapy alone. The study also met its secondary endpoints of improved PFS and objective response rate.
“We are pleased to have received breakthrough therapy designation for our novel PD-1 blocking antibody, toripalimab, for nasopharyngeal carcinoma, which is an aggressive cancer with no immuno-oncology treatment options approved in the United States,” Patricia Keegan, MD, chief medical officer of Junshi Biosciences, said in a company-issued press release. “We look forward to working closely with the FDA during the BLA review process and with our partner, Coherus, to bring toripalimab to [patients with nasopharyngeal carcinoma] in the U.S., if approved.”
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