Johnson & Johnson Secures Chinese Approvals for Two Novel Oncology Therapies Targeting NSCLC and Relapsed/Refractory Multiple Myeloma

　　【Pharmaceutical Network Enterprise NewsOn February 11, Johnson & Johnson announced that two new drugs have been approved in China, with indications including lung cancer and multiple myeloma.
 

Among the announcements, Johnson & Johnson declared that its innovative therapeutic drug Rykif® (Amivantamab Injection) has officially received approval from the National Medical Products Administration (NMPA). It is to be administered 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.
 

The approval of the drug marks Johnson & Johnson's official entry into the lung cancer treatment field in China. Relevant personnel from Johnson & Johnson stated that the approval of Rikoo will bring more survival hope to patients with EGFR-mutated non-small cell lung cancer, and is expected to further reshape the treatment landscape of non-small cell lung cancer in China. This also marks Johnson & Johnson's official entry into the lung cancer field in China, achieving an important breakthrough in the field of precision medicine.
 

It is reported that lung cancer is the malignant tumor with the highest incidence rate, and non-small cell lung cancer is the most common type of lung cancer. Among these, the EGFR gene mutation is a common driver gene in non-small cell lung cancer, with about 40% of patients in China carrying this mutation type.
 

Amivantamab, developed by Johnson & Johnson, is an investigational fully human bispecific antibody targeting EGFR and MET. In addition to blocking EGFR- and MET-mediated signaling, it can also direct immune cells to target tumors carrying activating and resistance EGFR/MET mutations and amplifications.
 

In China, Amivantamab was included in the CDE's breakthrough therapy designation in 2020 for the treatment of patients with metastatic or surgically unresectable NSCLC who have progressed during or after platinum-based doublet chemotherapy, or are intolerant to platinum-based chemotherapy, and have EGFR exon 20 insertion mutations. The approval of Amivantamab in China is based on the results of the randomized, open-label, PAPILLON phase 3 clinical study.
 

On the same day, Johnson & Johnson also announced that its first bispecific antibody drug targeting GPRC5D, Talquetamab Injection (brand name: Torlichem), has been officially approved by the National Medical Products Administration (NMPA). The drug is indicated as a monotherapy for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
 

Multiple myeloma is an incurable blood cancer with a 5-year relative survival rate of 59.8%. While some people diagnosed with multiple myeloma may initially have no symptoms, most patients are diagnosed with symptoms that may include fractures or pain, low red blood cell counts, fatigue, high calcium levels, and kidney problems or infections.
 

Talquetamab, as a bispecific antibody, can bind to the CD3 receptor expressed on the surface of T cells and GPRC5D. GPRC5D is a novel target for multiple myeloma, highly expressed on multiple myeloma cells, non-malignant plasma cells, and some healthy tissues such as skin and tongue epithelial cells. Targeting GPRC5D has been shown to provide deep responses, and unlike many other targets, its expression is limited to immune cells, offering a new approach to targeting this heterogeneous disease. Previously, talquetamab received Breakthrough Therapy Designation and Orphan Drug Designation from the U.S. FDA, followed by accelerated approval.
 

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