News Related to EGFR Exon 19 Deletion

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FDA Approves Monthly Subcutaneous Amivantamab Dosing for EGFR-Mutated NSCLC

Feb 21, 2026

The FDA has approved a once-monthly dosing schedule for subcutaneous amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) combined with lazertinib for first-line treatment of EGFR-mutated advanced NSCLC, based on PALOMA-2 trial data showing comparable efficacy to biweekly dosing.

FDA Approves Monthly Dosing for Rybrevant Faspro in EGFR-Mutated NSCLC, Grants Breakthrough Status

Feb 17, 2026

The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.