Major Breakthrough: Johnson & Johnson’s Rybrevant® (Amivantamab) Approved in China for First-Line Treatment of EGFR Exon 20 Insertion-Mutated NSCLC

On February 11, 2025, Johnson & Johnson announced that its innovative therapeutic drug Ryvec® (Amivantamab Injection) has been officially approved by the National Medical Products Administration for administration 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) whose tumors have been detected to carry epidermal growth factor receptor (EGFR) exon 20 insertion mutations.. This approval marks Johnson & Johnson's official entry into the lung cancer treatment field in China, with the potential to redefine treatment standards and usher in a new era of lung cancer therapy.

The approval of Amivantamab is based on the results of the randomized, open-label, PAPILLON Phase III clinical trial. The study demonstrated that, compared to chemotherapy alone, the combination of Amivantamab and chemotherapy reduced the risk of disease progression or death by 61%. Based on the results of the PAPILLON clinical trial, the National Comprehensive Cancer Network (NCCN) "NCCN Clinical Practice Guidelines" recommend Amivantamab in combination with chemotherapy as the preferred first-line treatment for patients with EGFR exon 20 insertion-mutated non-small cell lung cancer.

Lung cancer ranks first in both incidence and mortality among all malignant tumors in China. According to statistics, there are over 1 million new cases of lung cancer annually in China, accounting for more than one-third of the global total of lung cancer patients. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, comprising approximately 85% of all cases. Among these, EGFR gene mutations are the most common driver mutations in non-small cell lung cancer, with about 40% of patients in China carrying this mutation. Currently, 25%-40% of patients with EGFR mutations cannot proceed to second-line treatment due to severe disease progression. EGFR exon 20 insertion mutations represent the third most common mutation type. Typically, NSCLC driven by this mutation has a poorer prognosis and shorter survival compared to those driven by common EGFR mutations. Research shows that NSCLC patients with EGFR exon 20 insertion mutations have limited efficacy with currently approved third-generation EGFR-TKI targeted therapies and chemotherapy, resulting in generally poor outcomes and facing dual challenges of survival time and quality of life. Therefore, providing more effective treatment options during the first-line treatment phase is crucial.

Cherry Huang, President of Johnson & Johnson Innovative Pharmaceuticals, ChinaStated: "With a patient-centered approach, Johnson & Johnson has been committed to helping patients achieve higher treatment goals throughout its more than 30 years of dedication to the oncology field, aiming to make cancer a controllable and treatable chronic disease while leading the exploration for potential cures. In China, lung cancer is the leading type of cancer, with significant unmet treatment needs that urgently require more effective therapies. The recent approval of Rykindo® will bring more survival hope to patients with EGFR-mutated non-small cell lung cancer, potentially reshaping the treatment landscape for non-small cell lung cancer in China. This also marks Johnson & Johnson's official entry into the lung cancer field in China, representing a significant breakthrough in the area of precision medicine."

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