Janssen-Cilag International NV, affiliated to drug major Johnson & Johnson (JNJ), announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has recommended the approval of RYBREVANT (amivantamab) in combination with chemotherapy to treat adult patients with advanced epidermal growth factor receptor or EGFR-mutated non-small cell lung cancer after failure of prior therapy.
Non-Small Cell Lung Cancer or NSCLC accounts for 85 percent of all cases of lung cancer, which is Europe's biggest cancer killer.
Lazertinib, an oral, third-generation, brain-penetrant EGFR TKI, targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. Janssen Biotech, Inc. is developing lazertinib following a license and collaboration agreement with Yuhan Corp.
The positive opinion is for the approval of a Type II extension of indication for RYBREVANT (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) to treat adult patients with advanced NSCLC with EGFR Exon 19 deletions (ex19del) or Exon 21 L858R (L858R) substitution mutations, after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).
The CHMP recommendation is supported by data from the Phase 3 MARIPOSA-2 study, in which amivantamab in combination with chemotherapy significantly reduced the risk of disease progression or death by 52 percent compared to chemotherapy alone. It is the first treatment regimen to show improvement in progression-free survival in this patient population.
Kiran Patel, Vice President, Clinical Development, Solid Tumours, Johnson & Johnson Innovative Medicine, said, "Amivantamab has already shown positive outcomes in treating patients with other EGFR mutations, and we now look forward to the next steps in making it available to further patients with common EGFR mutations after progression on osimertinib."
On the NYSE, Johnson & Johnson shares were trading at $160.63, up 0.62%.
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