Johnson & Johnson (J&J) has announced that an injectable version of Rybrevant (amivantamab) has been approved by the European Commission (EC) for two advanced non-small cell lung cancer (NSCLC) indications.
The subcutaneous (SC) formulation of the drug has been approved in combination with J&J’s Lazcluze (lazertinib) as a first-line treatment for adults with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for adults with activating EGFR exon 20 insertion mutations who have failed platinum-based therapy.
NSCLC accounts for approximately 85% of all lung cancer cases, and alterations in EGFR are among the most common driver mutations in patients with this form of the disease.
J&J’s Rybrevant is already approved in the EU to treat certain NSCLC patients as an intravenous (IV) infusion.
It is hoped that the SC formulation, co-formulated with Halozyme’s Enhanze drug delivery technology, will improve the treatment experience for patients by significantly reducing administration time while also lowering rates of infusion-related reactions.
The approval follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by results from the phase 3 PALOMA-3 study, which demonstrated that SC Rybrevant was non-inferior to IV Rybrevant.
At a median follow-up of seven months, the overall response rate was 30% in the SC group and 33% for the IV cohort.
Administration time for SC Rybrevant was also reduced to around five minutes compared to around five hours for the first IV Rybrevant infusion, and there was a five-fold reduction in infusion-related reactions in the SC arm.
Henar Hevia, senior director, EMEA therapeutic area lead, oncology, J&J Innovative Medicine, said: “The approval of SC [Rybrevant] represents a welcome improvement of the treatment experience for both patients living with EGFR-mutated advanced NSCLC and the healthcare professionals who support them.
“This advancement presents an important opportunity to reduce the treatment burden, improve quality of life and give patients more time to focus on what truly matters to them.”