The FDA granted accelerated approval to Rybrevant Faspro for head and neck cancer
In a 102-patient trial, subcutaneous amivantamab, sold as Rybrevant Faspro, produced a 42 percent overall response rate in recurrent or metastatic head and neck cancer after chemo and immunotherapy. Confirmatory studies are required.
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The Food and Drug Administration granted accelerated approval to Rybrevant Faspro, a subcutaneous form of amivantamab, for recurrent or metastatic head and neck squamous cell carcinoma after chemotherapy and immunotherapy. In a trial of 102 patients, the overall response rate was 42 percent. The agency said that is more than double the rates typically seen with approved options in this setting.
Accelerated approval still requires confirmatory studies. A response rate is not a cure, and it does not say how long any one patient will live. The 42 percent figure is the share of patients in that 102-person trial whose cancers responded.
Health & Tech in MarylandSilver Spring, MarylandMedical researchCancer supportPublic healthGood news on November 6
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