Johnson & Johnson's (JNJ.US) Evolocumab combination therapy has been approved for use in China for the treatment of lung cancer in the first-line setting.

On February 11, Johnson & Johnson (JNJ.US) announced that its injectable evolocumab has been approved by the National Medical Products Administration (NMPA) of China. Evolocumab (amivantamab) is a dual-specificity antibody therapy targeting EGFR/MET, which has been approved for use in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been confirmed to carry EGFR exon 20 insertion mutations. Evolocumab (Rybrevant) is a fully humanized bispecific antibody being developed by a Johnson & Johnson subsidiary that targets EGFR and MET, in addition to blocking the signaling mediated by EGFR and MET, it can also guide immune cells to target tumors with active and resistant EGFR/MET mutations and amplifications. In China, evolocumab was included in the breakthrough therapy designation by the Center for Drug Evaluation (CDE) in 2020 for the treatment of patients with metastatic or unresectable NSCLC who have EGFR exon 20 insertion mutations, who have progressed during or after platinum-based doublet chemotherapy or who are intolerant to platinum-based chemotherapy. According to Johnson & Johnson's press release, the approval of evolocumab was based on the results of a randomized, open-label, PAPILLON clinical 3rd phase study, which showed that the risk of disease progression or death was reduced by 61% compared with chemotherapy alone.