Janssen submits sBLA for expanded Rybrevant approval to FDA

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application, or sBLA, to the U.S. Food and Drug Administration seeking the expanded approval of Rybrevant in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer, or NSCLC, with epidermal growth factor receptor exon 20 insertion mutations. “The sBLA is being reviewed by the FDA through the Real-Time Oncology Review – RTOR – program,” the company noted.