Nanjing Sanhome Pharmaceutical Co., Ltd has received approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug oritinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for EGFR T790M mutation in patients who have confirmed disease progression during or after previous treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs).
The pivotal Phase II SHC013-II-01 study demonstrated that Sanhome’s next-generation EGFR kinase inhibitor significantly improved outcomes in locally advanced or metastatic NSCLC with positive EGFR T790M mutation. The study reported an objective response rate (ORR) of 60.8%, a disease control rate (DCR) of 92.5%, a median progression-free survival (PFS) of 12.2 months, and a median duration of response (DoR) of 13.9 months. Furthermore, the Phase III SHC013-III-01 study showed that oritinib, compared to gefitinib as a first-line treatment for patients with locally advanced or metastatic NSCLC with EGFR sensitive mutations, provided greater survival benefits, with a median PFS of 19.3 months versus 9.8 months for gefitinib. In both clinical trials, oritinib exhibited good safety and tolerability profiles.- Flcube.com
