The agent, first approved in December for biweekly subcutaneous injection for EGFR-mutated NSCLC, showed similar efficacy and safety when administered monthly.

Rybrevant Faspro is a subcutaneous co-formulation of amivantamab, a bispecific EGFR-directed and MET receptor-directed antibody, and hyaluronidase.

Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for subcutaneous amivantamab and hyaluronidase-lpuj as ...

New designation is based on data showing rapid and durable responses in a heavily pretreated patient population and expands the promise of RYBREVANT FASPRO beyond lung ...

J&J has received the US FDA approval for a new monthly dosing schedule for the combination therapy Rybrevant Faspro to treat ...

The agency last December approved subcutaneous Rybrevant on a biweekly dosing schedule across all of its indications.

The FDA has approved a monthly dosing schedule for subcutaneous amivantamab in NSCLC following the first 4 weeks of treatment ...

The FDA approved a once-monthly Rybrevant Faspro schedule with Lazcluze for first-line EGFR-mutated advanced NSCLC, reducing visits.

The U.S. Food and Drug Administration (FDA) on Tuesday approved a new, simplified monthly dosing schedule for Johnson & ...

FDA approves monthly subcutaneous amivantamab plus lazertinib for EGFR-mutated advanced NSCLC, cutting clinic time and ...

FDA approved a simplified, once-monthly dosing schedule for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) when used in combination with Lazcluze (lazertinib) as a first-line treatment for ...