The approval covers all existing indications for Rybrevant.
The SC formulation reduces administration time from several hours to five minutes, compared to intravenous (IV) delivery, offering increased patient convenience and decreasing healthcare resource use.
Rybrevant’s approval is supported by results from the Phase III PALOMA-3 study, which demonstrated that the therapy met both co-primary pharmacokinetic endpoints.
These findings were initially presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology.
Further PALOMA-3 data showed that the SC arm, in combination with Lazcluze (lazertinib), had longer overall survival (OS), longer duration of response, and improved progression-free survival compared to the IV arm. At 12 months, 65% of patients in the SC group were alive, against 51% in the IV group.
J&J’s innovative medicine solid tumour president Biljana Naumovic said: “The approval of Rybrevant Faspro is a pivotal step forward, as EGFR+ NSCLC patients have previously faced limited treatment options.
“Now, patients are gaining greater access to this transformative treatment, as well as the tools needed to proactively manage common dermatological effects.”
The safety profile of Rybrevant Faspro in combination with Lazcluze was found to be largely consistent with IV administration.
Common adverse reactions (≥ 20%) of the combination included musculoskeletal pain, haemorrhage, decreased appetite, and peripheral neuropathy.