Loqtorzi becomes ninth US anti-PD-(L)1 drug

Nearly two years after first being filed, and with a complete response letter and missed PDUFA date under its belt, Coherus/Shanhgai Junshi’s toripalimab has been approved in the US at last. The anti-PD-1 drug, trademarked Loqtorzi, has been available in China since 2018, and boasts six indications there, but its US greenlight on Friday marks the unblocking of a US regulatory pathway that had stalled with China’s Covid-related travel restrictions. This bodes well for pending approvals of penpulimab, tislelizumab and camrelizumab, though sintilimab and sugemalimab’s attempts in NSCLC, a major indication using China-only data, have been torpedoed by the FDA. Coherus/Junshi point out that Loqtorzi binds to a unique site on PD-1, and is the first ever anti-PD-(L)1 drug to secure US approval for nasopharyngeal carcinoma – Keytruda had failed here in the Keynote-122 trial – but its main potential might be as a backbone for combo therapy. Among other relative latecomers to this US scene, GSK’s Jemperli today scored in the Ruby trial in endometrial cancer, this time showing an overall survival benefit for a chemo combo versus chemo alone in dMMR/MSI-high as well as MMR-proficient/microsatellite-stable subgroups. The drug is at present approved only in the former setting. 

Selected anti-PD-(L)1 latecomers

Source: OncologyPipeline.