Junshi Biosciences, Coherus Receive FDA Breakthrough Therapy Status For Toripalimab In Head & Neck Cancer

The FDA has granted Breakthrough Therapy Designation (BTD) to Shanghai Junshi Biosciences Co Ltd - Coherus BioSciences Inc's CHRS toripalimab for recurrent or metastatic nasopharyngeal carcinoma (NPC).
NPC is a rare tumor of the head and neck.
The designation covers toripalimab combined with chemotherapy (gemcitabine and cisplatin) for the 1st line treatment of NPC.
The FDA had earlier granted BTD for toripalimab monotherapy for patients with recurrent or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
Price Action: CHRS shares are up 7.04% at $14.30 during the premarket session on the last check Thursday.
Related content: Benzinga's Full FDA Calendar.