Johnson & Johnson (JNJ) said Monday that Health Canada authorized lazcluze in combination with rybrevant as a first-line treatment for certain patients with advanced non-small cell lung cancer.
The company said the approval is based on a phase 3 study of the combination in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations.
The trial showed that the combination reduced the risk of disease progression or death by 30% compared with osimertinib, with a median progression-free survival of 23.7 months versus 16.6 months, according to Johnson & Johnson. The median duration of response was 25.8 months, nine months longer than with osimertinib, the company said.
The drugmaker said its Janssen unit holds marketing authorization for lazcluze and rybrevant in Canada.
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