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The FDA has approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Johnson & Johnson), a subcutaneous formulation of the bispecific antibody amivantamab (Rybrevant), for patients with EGFR-mutated non-small cell lung cancer (NSCLC).
The subcutaneous version carries the same indications as the intravenous (IV) formulation, which include first- and second-line combination treatment of patients with EGFR-aberrant advanced or metastatic NSCLC, as well as a monotherapy indication after progression on platinum-based chemotherapy.
The shot reduces administration time from hours to minutes and is far more convenient for patients and providers, Johnson & Johnson said in a press release.
Approval was based on the PALOMA-3 trial. A total of 418 patients with previously treated EGFR-mutated locally advanced or metastatic NSCLC were randomized equally to either the IV or subcutaneous formulations in combination with lazertinib (Lazcluze).
Pharmacokinetics were similar or better with the subcutaneous version, and there were no differences in overall response rates or progression-free survival. However, 65% of patients in the subcutaneous arm were alive at 12 months compared with 51% percent of those in the IV arm, according to Johnson & Johnson.
There were also fewer systemic administration reactions with the subcutaneous vs IV formulation (13% vs 66%) and fewer venous thromboembolisms (11% vs 18%), according to the company.
Labeling warns of hypersensitivity and administration-related reactions, interstitial lung disease or pneumonitis, venous thromboembolic events with concomitant use of lazertinib, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity.
Dosing with either formulation is weight-based and dependent on indication. Rybrevant Faspro pricing was unavailable at press time.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com.
