FDA Grants Orphan Drug Designation to Coherus Biosciences’ Toripalimab for Small Cell Lung Cancer
The FDA granted orphan drug status to Coherus Biosciences’ Toripalimab (TuoYi) based on data from the phase 3 JUPITER-08 study in patients with extensive-stage Small-cell Lung Cancer (ES-SCLC). Patients in the current randomized, double-blind trial are getting toripalimab, a PD-1 inhibitor, plus a platinum-based chemotherapeutic such as cisplatin or carboplatin, and etoposide as first-line therapy for ES-SCLC, as opposed to placebo plus the same chemotherapy backbone. The trial is estimated to enroll 420 patients who will get a toripalimab or placebo injection paired w...