The FDA has approved J&J’s Rybrevant FASPRO (amivantamab and hyaluronidase-lpuj), a subcutaneous formulation of amivantamab, for all existing Rybrevant indications in epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). The product is approved for use in combination with Lazcluze (lazertinib) in the first-line setting and in several combinations or as monotherapy in later lines for specific EGFR mutation subtypes.
Rybrevant FASPRO is administered subcutaneously and is positioned as an alternative to intravenous (IV) amivantamab regimens. According to Johnson & Johnson, the subcutaneous injection reduces administration time from several hours with IV dosing to about five minutes and is associated with a lower rate of administration-related reactions and venous thromboembolism compared with IV administration in clinical studies.
The approval is supported by the Phase 3 PALOMA-3 trial, which evaluated subcutaneous amivantamab plus lazertinib versus IV-based regimens and met co-primary pharmacokinetic endpoints showing exposure comparable to IV administration. Data presented from PALOMA-3 indicated longer duration of response, improved progression-free survival, and higher 12‑month overall survival for the subcutaneous arm compared with IV amivantamab when combined with lazertinib.
The subcutaneous formulation builds on results from the Phase 3 MARIPOSA study, where IV Rybrevant plus Lazcluze reduced the risk of death versus osimertinib in untreated, locally advanced or metastatic EGFR exon 19 deletion or L858R NSCLC. At a median follow-up of 37.8 months, overall survival with the combination had not yet been reached and was projected to exceed four years, compared with about three years for osimertinib.
The safety profile of Rybrevant FASPRO in combination with Lazcluze was generally consistent with IV amivantamab, with rash, nail toxicity, musculoskeletal pain, edema, fatigue and nausea among the most common adverse reactions. Johnson & Johnson is providing patient support and reimbursement resources through its Rybrevant withMe program to facilitate access to the new formulation.
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