💊 FDA OKs Rybrevant SC for EGFR+ NSCLC—A First-in-Class

Johnson & Johnsons Rybrevant Faspro (amivantamab/hyaluronidase-lpuj) is now the first subcutaneous therapy approved by the FDA for EGFR-mutated nonsmall-cell lung cancer (NSCLC), supported by Phase III PALOMA-3 data.

Why It Matters To Oncology

▪ SC Rybrevant offers faster administration (five minutes vs. hours) and fewer infusion reactions compared to IV, potentially transforming patient experience and resource use.

▪ PALOMA-3 demonstrated noninferiority on pharmacokinetics and improved duration of response, PFS, and 12-month OS, especially when combined with lazertinib.

▪ Expands options for EGFR-mutated NSCLC, a population with few targeted therapies.

The Financials

▪ Rybrevant (including SC) is projected as a key driver for J&Js oncology portfolio, with estimated peak franchise revenue of $5B and total oncology sales target of $50B by 2030.

▪ SC formulation leverages Halozymes Enhanze technology, aiming to recapture share from AstraZenecas Tagrisso.

What They're Saying

▪ J&Js Biljana Naumovic called the approval “transformative,” highlighting greater access and proactive management of dermatologic side effects.

▪ Analysts see the SC version as critical for J&Js competitive position in EGFR-mutated NSCLC.

What's Next

▪ Commercial uptake will be closely watched against entrenched competitors like Tagrisso.

▪ Ongoing studies may further clarify SC Rybrevants role in first-line and combination regimens.