Johnson & Johnson Launches Rybrevant in China for EGFR Exon 20 Insertion Mutation Lung Cancer

Johnson & Johnson Launches Rybrevant in China for EGFR Exon 20 Insertion Mutation Lung Cancer

US pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has officially launched Rybrevant (amivantamab), an EGFR-MET bispecific antibody (BsAb) for lung cancer, in China. The drug received marketing approval from the National Medical Products Administration (NMPA) in February 2024, marking a significant advancement in the treatment of non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.

Regulatory Approval and Clinical Evidence
Rybrevant is approved for use in combination with carboplatin and pemetrexed as a first-line treatment for locally advanced or metastatic NSCLC in adult patients confirmed to carry the EGFR exon 20 insertion mutation. The NMPA’s decision was based on positive results from the Phase III PAPILLON study, which demonstrated that the amivantamab combination reduced the risk of disease progression or death by 61% compared to chemotherapy alone. This approval follows the drug’s initial approval in the US in May 2021.

Market and Financial Impact
The launch of Rybrevant in China expands J&J’s footprint in the global oncology market, addressing a significant unmet need for patients with this specific genetic mutation. The therapy’s robust clinical profile positions it as a new standard of care and is expected to contribute to J&J’s growing portfolio of innovative cancer treatments.-Fineline Info & Tech