Johnson & Johnson Launches Amivantamab in China, Marking Entry into Lung Cancer Therapeutics
Johnson & Johnson
Medical Device R&D and Manufacturer
In February this year, Johnson & Johnson announced that the EGFR/MET bispecific antibody therapy, amivantamab injection, had been approved by the NMPA for marketing in China. It is to be used 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 epidermal growth factor receptor (EGFR) exon 20 insertion mutations as confirmed by testing.
On April 12, Johnson & Johnson announced,The official launch of Amivantamab Injection in China marks Johnson & Johnson's entry into the lung cancer treatment field in China.
EGFR exon 20 insertion mutation is the third most common type of mutation. Non-small cell lung cancer (NSCLC) driven by this mutation typically has a poorer prognosis and shorter survival compared to NSCLC driven by common EGFR mutations. Moreover, patients show limited response to currently approved third-generation EGFR-TKI targeted therapies and chemotherapy, creating an urgent need for new first-line treatment options. Amivantamab in combination with chemotherapy has been recommended by the NCCN Clinical Practice Guidelines as the preferred first-line treatment for NSCLC patients with EGFR exon 20 insertion mutations. The phase 3 PAPILLON clinical study shows,Compared with chemotherapy alone, the combination of amivantamab and chemotherapy reduced the risk of disease progression or death by 61%.。
In Q2 this year, the new lung cancer drugs that are about to be launched in China also includeHengrui's Rui Kang Trastuzumab, andGorelyse by JACOBIO.
Trastuzumab Rui Kang:On September 14, 2024, the HER2 ADC independently developed by HengruiTrastuzumab Rui KangMarketing application accepted for the treatment of adult patients with locally advanced or metastatic HER2-mutant non-small cell lung cancer (NSCLC) who have previously received at least one systemic therapy. The application has been granted priority review by the CDE. Notably, this is also the first in China.The First Chinese-produced HER2 ADC Submitted for Marketing in the NSCLC Field。
Gore Release:On May 22, 2024, Jacobio's Golefosib application was accepted and included in the priority review process for the treatment of second-line and above advanced or metastatic cases with KRAS G12C mutations.NSCLCPatient. Data show that in second-line NSCLC patients treated with monotherapy, GorletrectinibThe confirmed objective response rate (ORR) was 47.9%, the median progression-free survival (mPFS) was 8.2 months, and the median overall survival (mOS) was 13.6 months.。
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