After receipt of a complete response letter in May 2022, a biologics license application for toripalimab monotherapy in the second line or later following platinum chemotherapy or in combination with chemotherapy in the first-line setting for advanced recurrent or metastatic nasopharyngeal carcinoma was resubmitted to and accepted by the FDA.
A biologics license application (BLA) for toripalimab plus gemcitabine and cisplatin as first-line treatment or alone in the second-line or later setting following a platinum-containing regimen for patients with advanced recurrent or metastatic nasopharyngeal carcinoma was resubmitted to and accepted by the FDA following a complete response letter earlier this year, according to a press release from Coherus BioSciences.1
The BLA will be reviewed over the next 6 months, with a prescription drug user free act date of December 23, 2022. If approved, the agent will be launched in the first quarter of 2023.
“Toripalimab would address a critical unmet medical need for patients with nasopharyngeal carcinoma, an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments. We collaborated closely with our partner, Junshi Biosciences, to complete the quality process changes requested by the FDA and facilitate the rapid resubmission of the toripalimab BLA,” Theresa LaVallee, PhD, chief development officer at Coherus, said in the press release.
A complete response letter was issued by the FDA for toripalimab in May 2022, with the organization citing a need for quality process change.2 Moreover, mandatory site inspections were hindered by travel restrictions due to the COVID-19 pandemic.
The BLA for toripalimab was originally accepted and granted priority review by the FDA in November 2021 based on data from multiple clinical trials. Findings from the phase 2 POLARIS-02 trial (NCT02915432) indicated that patients who received 3 mg/kg of toripalimab every 2 weeks (n = 190) experienced an overall response rate of 20.5% with a median duration of response of 12.8 months.3 Moreover, the median progression-free survival (PFS) in the population was 1.9 months and the median overall survival was 17.4 months. In the phase 3 JUPITER-02 trial (NCT03581786)—in which patients received 240 mg of toripalimab plus gemcitabine/cisplatin for 3 weeks and maintenance toripalimab vs matched placebo—the median PFS in the experimental arm was 11.7 months vs 8.0 months in the placebo arm (stratified HR, 0.52; 95% CI, 0.36-0.74; P = .0003).4
“Although the COVID-19 pandemic has created tremendous challenges for everyone, our dedication to bring better treatment options to patients around the world remains steadfast. Through our concerted efforts with our partner, Coherus, we have made continual progress towards obtaining toripalimab’s first marketing authorization outside of China. Over the next several months, we will work closely with the FDA to facilitate the review of this novel drug,” Patricia Keegan, MD, chief medical officer at Junshi Biosciences, concluded.