Progress for Johnson & Johnson’s lung cancer drug

The company is seeking approval of Rybrevant (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed), a drug it believes has the potential to offer a new standard of care to patients.

The  treatment is for adult patients with advanced non-small cell lung cancer (NSCLC) with a mutated form of the protein epidermal growth factor receptor (EGFR).

The European Medicines Agency (EMA) defines a type 2 variation as any major variation that may have a significant impact on the quality, safety, or efficacy of a medicinal product. An application for an extension of a therapeutic indication is considered a major variation and is therefore classified as a specific form of type 2 variation.

Resistance mechanisms

“Patients with EGFR-mutated advanced non-small-cell lung cancer treated with osimertinib inevitably develop resistance mechanisms and are faced with poor outcomes on platinum-based chemotherapy alone,” said Catherine Taylor, vice president, of EMEA medical affairs.

Therapy area strategy, Janssen-Cilag AG. “Amivantamab is active against a wide range of EGFR and MET alterations, which are key mechanisms of resistance to osimertinib. The addition of amivantamab to chemotherapy has demonstrated the potential to address post-osimertinib resistance while supporting longer disease control.”

In December last year (2022) amivantamab was granted a conditional marketing authorization by the European Commission. This was the first fully human, bispecific antibody for the monotherapy treatment of adult patients with advanced NSCLC with a specific form of mutated EGFR after failure of platinum-based chemotherapy.

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