Johnson & Johnson said Monday, local time, that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of an expanded indication for the subcutaneous formulation of Rybrevant (amivantamab).

Upon final approval by the EMA, Rybrevant will be available in combination with Leclaza (lazertinib), marketed as Lazcluze overseas, for the first-line treatment of EGFR exon 19 deletion or exon 21 L858R mutant non-small cell lunger cancer (NSCLC), or as monotherapy for patients with EGFR exon 20 insertion mutations following platinum-based chemotherapy.

The dose is 1600 mg (2240 mg for patients weighing 80 kg or more) weekly for weeks 1-4 and every two weeks from week 5.

“The subcutaneous formulation of amivantamab reduces the dosing time from hours to minutes and significantly reduces the incidence of infusion-related reactions compared to the existing intravenous formulation,” said Professor Silvia Novello of the Department of Oncology at San Luigi Hospital, University of Turin. “This positive opinion from the CHMP is an important step forward in treating EGFR-mutant NSCLC and will allow us to offer patients a better treatment experience.”

The PALOMA-3 phase 3 study demonstrated non-inferiority in blood levels of amivantamab between the subcutaneous and intravenous arms. At a median follow-up of seven months, the overall response rate was 30 percent (95 percent CI, 24-37 percent) in the subcutaneous arm and 33 percent (95 percent CI, 26-39 percent) in the intravenous arm.

Administration time was five minutes, about five hours shorter than the first intravenous infusion, and the incidence of infusion-related reactions was fivefold reduced (13 percent vs. 66 percent). The incidence of venous thromboembolism was also lower (9 percent vs. 14 percent) and further reduced in the anticoagulation prophylaxis arm (10 percent vs. 21 percent).

“This positive recommendation from the CHMP marks an important milestone in our ability to deliver a subcutaneous formulation with improved safety and patient convenience while maintaining the proven efficacy of intravenous amivantamab,” said Dr. Hennar Hebia, head of Oncology for EMEA (Europe, Middle East, and Africa) at Johnson & Johnson Innovative Medicines.

Dr. Joshua Baum, head of Lung Cancer Disease at Johnson & Johnson Innovative Medicines, said, “By bringing a new treatment option to patients in Europe, we hope to improve outcomes for EGFR-mutant NSCLC.”