J&J wins FDA approval for chemo-free treatment for lung cancer - European Medical Journal

J&J wins FDA approval for chemo-free treatment for lung cancer

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EMJ GOLD
Words by Jade Williams

The FDA has approved Johnson & Johnson’s new chemotherapy-free combination treatment, which could replace the current standard of care for patients with a type of non-small cell lung cancer (NSCLC).  

The regimen combines J&J’s innovative cancer drug Amivantamab with lazertinib, an older therapeutic agent, as a first-line treatment for NSCLC patients who exhibit a mutation in the epidermal growth factor receptor (EGFR) gene.  

NSCLC remains the most prevalent form of lung cancer, with EGFR gene mutations present in approximately 10-15% of cases in the US based on data from the American Lung Association. 

The FDA’s decision was based on robust data from a pivotal Phase 3 trial that showed the new combination extended progression-free survival compared to AstraZeneca’s widely used frontline treatment in this patient population, which is followed by chemotherapy. This new approval positions J&J’s combination as a promising chemotherapy-free alternative.

J&J is preparing for an imminent launch of the therapy, with Biljana Naumovic, Executive, J&J, who leads the commercial strategy for the company’s oncology division, telling Reuters that it is “the first chemo-free therapy that beat the standard of care in the frontline setting”, underlining the breakthrough status this treatment could have in this disease area.

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