The MAA submission to the MHRA for NPC and ESCC indications is based on findings from the JUPITER-02 and JUPITER-06 phase 3 clinical trials
Junshi Biosciences has filed MAA to the UK’s MHRA for toripalimab. (Credit: Julia Koblitz on Unsplash)
Shanghai Junshi Biosciences has filed a marketing authorisation application (MAA) for toripalimab to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for two indications.
One of the indications sought is for using toripalimab in combination with cisplatin and gemcitabine for the treatment of locally recurrent or metastatic nasopharyngeal carcinoma (NPC) in the first-line setting.
The other indication is to use toripalimab in combination with paclitaxel and cisplatin for the treatment of esophageal squamous cell carcinoma (ESCC) in patients whose conditions are unresectable locally advanced/recurrent or metastatic.
Earlier this month, Junshi Biosciences submitted an application to the European Medicines Agency (EMA) seeking approval for toripalimab for the same indications.
Toripalimab is an anti-PD-1 monoclonal antibody designed to inhibit PD-1 interactions in order to attack and destroy tumour cells.
The biopharmaceutical firm said that the MAA submission for nasopharyngeal carcinoma and esophageal squamous cell carcinoma is backed by the results of the JUPITER-02 and JUPITER-06 phase 3 trials.
In the JUPITER-02 trial, the toripalimab plus chemotherapy arm had a significantly longer progression-free survival (PFS) than the placebo plus chemotherapy arm.
According to Junshi Biosciences, the JUPITER-06 results demonstrated considerably better overall survival (OS) and PFS in the toripalimab plus chemotherapy arm compared to the placebo plus chemotherapy arm.
Junshi/TopAlliance Biosciences chief medical officer Patricia Keegan said: “Within a single month, we were able to submit marketing authorization applications for toripalimab to two major European regulatory agencies.
“This is emblematic of our determination and corporate efficiency in bringing innovative drugs to patients worldwide.
“In the coming days, we will work closely with the MHRA to promote the clinical development and application of emerging therapies in the UK.”
In 2021, China National Medical Products Administration (NMPA) approved two indications of toripalimab for the treatment of nasopharyngeal carcinoma.
In the US, toripalimab secured two breakthrough therapy designations and an orphan drug designation from the US Food and Drug Administration (FDA) for nasopharyngeal carcinoma indications.