FDA Grants Breakthrough Status To Johnson & Johnson's Cancer Drug For Advanced Head and Neck Cancer

FDA Designation - The FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as a monotherapy for adults with advanced head and neck squamous cell carcinoma [1] - The designation is for patients with recurrent or metastatic cancer that is HPV-unrelated after progression on platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor [2] - Rybrevant Faspro is also approved for multiple settings in locally advanced or metastatic non-small cell lung cancer and is being evaluated in additional solid tumors, including colorectal cancer [2] Clinical Studies - The Breakthrough Therapy Designation is supported by data from the open-label Phase 1b/2 OrigAMI-4 study, which showed promising clinical activity with rapid and durable responses in a heavily pretreated patient population [3] - Subcutaneous amivantamab is being further evaluated in the ongoing Phase 3 OrigAMI-5 study, assessing its combination with Merck's Keytruda and carboplatin versus 5-fluorouracil plus pembrolizumab and platinum-based chemotherapy for HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma [4] New Dosing Schedule - The FDA approved a new, simplified monthly dosing schedule for Rybrevant Faspro in combination with oral Lazcluze for the first-line treatment of EGFR-mutated advanced non-small cell lung cancer [5] Contract Extension - Trellus Health plc extended its contract with Johnson & Johnson's Health Care Systems unit for six months to continue providing Trellus Elevate for patients with moderate to severely active inflammatory bowel disease [6] - The extension was influenced by the achievement of engagement and satisfaction metrics during the initial pilot phase [6]