Two months after CRL, FDA accepts Coherus, Junshi's resubmission for PD-1 studied in China
China-only clinical data has not fared well before the FDA this year. But in one case, the regulatory agency might be willing to budge a little.
Coherus BioSciences, the US partner for Junshi Biosciences, announced Wednesday morning that the FDA has accepted a BLA resubmission for its PD-1 drug two months after a CRL. The companies are seeking a nod for toripalimab plus chemotherapy in first-line advanced recurrent or metastatic nasopharyngeal carcinoma (NPC), plus toripalimab alone for second-line and later recurrent or metastatic NPC after platinum-containing chemotherapy.