Janssen-Cilag International NV, a subsidiary of pharmaceutical giant Johnson & Johnson (JNJ), announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of RYBREVANT (amivantamab) combined with chemotherapy for adult patients with advanced epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC) following the failure of prior therapy.
Non-Small Cell Lung Cancer (NSCLC) constitutes 85 percent of all lung cancer cases, making it the leading cause of cancer-related deaths in Europe.
Lazertinib, an oral, third-generation, brain-penetrant EGFR tyrosine kinase inhibitor (TKI), is designed to target both the T790M mutation and other activating EGFR mutations, while sparing wild-type EGFR. Janssen Biotech, Inc. is developing lazertinib through a licensing and collaboration agreement with Yuhan Corp.
The CHMP's positive opinion recommends 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 previous therapy, including an EGFR TKI.
This recommendation is based on data from the Phase 3 MARIPOSA-2 study, which demonstrated that amivantamab combined with chemotherapy significantly lowered 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 demographic.
Kiran Patel, Vice President of Clinical Development for Solid Tumours at Johnson & Johnson Innovative Medicine, stated, "Amivantamab has already shown positive outcomes in treating patients with other EGFR mutations, and we are now looking forward to advancing its availability to more patients with common EGFR mutations who have progressed on osimertinib."
On the New York Stock Exchange (NYSE), Johnson & Johnson shares were trading at $160.63, an increase of 0.62%.
