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J&J's Rybrevant Faspro Granted FDA Breakthrough Therapy Status For Head And Neck Cancer

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Johnson & Johnson (JNJ) said on Wednesday that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as a monotherapy for adults with advanced head and neck squamous cell carcinoma.

The designation is supported by data from the Phase 1b/2 OrigAMI-4 study, in which Rybrevant Faspro demonstrated rapid and durable responses in a heavily pretreated patient population.

Rybrevant Faspro is approved in multiple settings for the treatment of non-small cell lung cancer and is also being evaluated in additional solid tumors, including colorectal cancer.

Johnson & Johnson shares closed at $243.33 on Tuesday, down 0.05%.

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