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Janssen Seeking Rybrevant-Chemo Approval in Europe for First-Line EGFR-Mutated NSCLC

NEW YORK – Janssen on Friday said it submitted an application to the European Medicines Agency seeking approval for Rybrevant (amivantamab) plus chemotherapy as a first-line option for advanced non-small cell lung cancer patients whose tumors harbor EGFR exon 20 insertion mutations.

The drugmaker submitted a Type II extension of indication application based on the results of the Phase III randomized PAPILLON clinical trial, in which patients lived longer without their cancers progressing when they received Rybrevant plus chemotherapy versus chemotherapy alone.  

In August, Janssen also filed a supplemental biologics licensing application with the US Food and Drug Administration seeking approval for this first-line indication. The EGFR-MET bispecific antibody is already approved on a conditional basis in Europe and the US as a single-agent for treating EGFR exon 20 insertion mutation-positive advanced NSCLC patients.

The drugmaker has previously said it hopes the PAPILLON clinical trial data will not only support Rybrevant's approval in the first-line NSCLC setting in combination with chemo, but also help convert the drug's accelerated approval in the later-line setting into a full approval.

Meanwhile, earlier this week, Takeda said it will voluntarily stop selling Exkivity (mobocertinib) globally as a treatment for EGFR exon 20 insertion-mutated advanced NSCLC after a confirmatory trial failed to prove it improved progression-free survival over platinum-based chemotherapy. With Exkivity's departure from the market, Rybrevant will be the only targeted treatment option for this subset of patients.