EMA Recommends Johnson & Johnson Subcutaneous Treatment for Non-Small Cell Lung Cancer

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an extension of marketing authorization for a subcutaneous formulation of the Johnson & Johnson products Rybrevant (amivantamab) in combination with Lazcluze (lazertinib) for first-line treatment of adults with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations (1).

In a press release announcing CHMP’s recommendation, Janssen-Cilag International NV, a Belgium-based company under the Johnson & Johnson umbrella, said the combination of subcutaneous amivantamab with lazertinib was also being recommended as a monotherapy for adults with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy (1).

The February 3 announcement comes shortly after Johnson & Johnson said on Jan. 21, 2025 that the European Commission had approved a marketing authorization for lazertinib in combination with amivantamab for first-line treatment of advanced EGFR-mutated NSCLC in adults, based on a Phase III trial that compared the combination of those two treatments to that of osimertinib (2).

In this case, another Phase III study (PALOMA) showed that subcutaneous amivantamab was non-inferior when compared to intravenous amivantamab—the currently approved route of administration—when both were combined with lazertinib in patients with EGFR-mutated advanced or metastatic NSCLC after progression on osimertinib and platinum-based chemotherapy (1).

“The subcutaneous formulation of amivantamab offers an improved treatment experience for patients, reducing administration time from hours to minutes and substantially lowering rates of infusion-related reactions compared to the currently approved intravenous therapy,” said Silvia Novello, MD, PhD, professor of Medical Oncology in the Oncology department at San Luigi Hospital in Orbassano, University of Turin, Italy, in the February 3 release. “This positive CHMP opinion is a welcome milestone in the treatment of EGFR-mutated NSCLC, with the ability to make a meaningful difference in clinical practice and provide patients with more time to spend with their loved ones and to focus on what matters most to them.”

“The positive CHMP recommendation for subcutaneous amivantamab takes us one step closer to making this a reality, providing the established efficacy benefits of IV amivantamab with improved safety outcomes and greater convenience for patients,” Henar Hevia, PhD, senior director, Europe, Middle East & Africa therapeutic area lead, oncology, Johnson & Johnson Innovative Medicine, said in the release.

It is recommended that subcutaneous amivantamab be administered weekly from weeks one to four of treatment, for a total of four doses, then every two weeks from the fifth week onward (1). At a median follow-up of seven months, overall response rate in the subcutaneous arm was 30%, versus 33% for intravenous, which met the non-inferiority criteria.

References

1. Johnson & Johnson. CHMP Recommends Subcutaneous Rybrevant (amivantamab) for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer. Press Release. Feb. 3, 2025.
2. Johnson & Johnson. European Commission Approves Lazcluze (lazertinib) in Combination with Rybrevant (amivantamab) for the First-Line Treatment of Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Press Release. Jan. 21, 2025.