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.
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