By Fineline Cube 
US giant Johnson & Johnson (J&J; NYSE: JNJ) announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its Rybrevant (amivantamab), an EGFR-MET bispecific antibody (BsAb) for lung cancer. The drug is now approved for use in combination with carboplatin and pemetrexed to treat locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation that has progressed during or after EGFR tyrosine kinase inhibitor treatment.
Clinical Trial Results
The approval is based on positive results from the Phase III MARIPOSA-2 study. Compared to the chemotherapy group alone, the combination of amivantamab and chemotherapy reduced the risk of disease progression or death by 52% and significantly improved the median progression-free survival (mPFS) of patients (6.3 months vs 4.2 months). The benefits of PFS in Asian populations were consistent with those globally (mPFS: 10.3 months vs 4.2 months).
Previous Approval and Market Context
Rybrevant was previously approved in China in February 2023 for use in combination with carboplatin and pemetrexed as first-line treatment for locally advanced or metastatic NSCLC adult patients confirmed to carry EGFR exon 20 insertion mutation through testing. This latest approval further expands the therapeutic applications of Rybrevant in China.-Fineline Info & Tech