FDA Approves New Administration Method for Rybrevant (amivantamab) 

On December 17, 2025, the U.S. Food and Drug Administration (FDA) approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for subcutaneous injection, commonly known as a shot. This approval included all the same uses of Rybrevant (amivantamab) that the FDA previously approved for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have an EGFR mutation.  

This latest approval is based on the results of the PALOMA-3 study, which compared the use of Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) given by a shot (injection) under the skin versus traditional Rybrevant (amivantamab), which is given as an infusion into the bloodstream (intravenous/IV). People given Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as a shot received the drug over approximately 5 minutes compared to the standard IV, which can sometimes take a few hours.   

The study showed both administration methods to be equally effective, and individuals receiving Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) by injection experienced significantly fewer administration-related reactions. This latest approval offers greatly improved patient convenience in receiving treatment and lowers the burden of healthcare resources needed. 

Please speak with your healthcare team for more information about Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) to see if it may be a good option for you. If you have questions about treatment, trials, or biomarker testing, contact our LungMATCH team at [email protected] or 1-800-298-2436.   

Read the full FDA announcement.