EC Approves Johnson & Johnson's Subcutaneous Rybrevant for NSCLC

Johnson & Johnson (J&J) recently received approval from the European Commission for its injectable form of Rybrevant (amivantamab), targeting two specific advanced non-small cell lung cancer (NSCLC) conditions. This subcutaneous (SC) version is approved to be used with J&J's Lazcluze (lazertinib) for first-line treatment in adults with specific epidermal growth factor receptor (EGFR) mutations, namely EGFR exon 19 deletions or exon 21 L858R substitution mutations. Additionally, it is authorized as a standalone treatment for adults with activating EGFR exon 20 insertion mutations who have not responded to platinum-based therapy.

NSCLC is a predominant form of lung cancer, constituting around 85% of all lung cancer cases, with EGFR mutations being among the most frequent genetic alterations driving the condition. Rybrevant was already available in the European Union for certain NSCLC patients as an intravenous (IV) infusion. The new SC formulation, developed in collaboration with Halozyme’s Enhanze drug delivery technology, aims to enhance patient experience by significantly reducing the time required for administration and decreasing the likelihood of infusion-related adverse reactions.

The European Commission's approval followed a favorable recommendation from the European Medicines Agency's human medicines committee. This decision was backed by data from the phase 3 PALOMA-3 study, which indicated that the SC formulation of Rybrevant was non-inferior to its IV counterpart. After a median follow-up period of seven months, the overall response rate was similar between the two groups: 30% for SC and 33% for IV administration. Notably, the time required to administer SC Rybrevant was significantly reduced to roughly five minutes, compared to approximately five hours for the initial IV infusion. Moreover, there was a remarkable five-fold decrease in infusion-related reactions among patients receiving SC Rybrevant.

Commenting on this development, Henar Hevia, the senior director and EMEA therapeutic area lead for oncology at J&J Innovative Medicine, remarked that the approval of the SC Rybrevant marks a significant enhancement in the treatment journey for patients with EGFR-mutated advanced NSCLC. He emphasized that this advancement not only reduces the treatment burden but also aims to improve patients' quality of life, allowing them to dedicate more time to aspects of life that are truly important to them.

The introduction of the SC formulation of Rybrevant reflects J&J's ongoing commitment to innovating cancer treatments, focusing on improving patient experience and outcomes. By addressing the logistical challenges associated with lengthy administration times and reducing adverse reactions, the new formulation is poised to provide a more convenient and patient-friendly treatment option for those battling this aggressive form of lung cancer. The healthcare community anticipates that these improvements will contribute positively to the management of NSCLC, offering a more efficient and comfortable treatment experience for both patients and healthcare professionals involved in their care.