China-based Chia Tai Tianqing has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The drug is approved as a first-line treatment for extensive stage small cell lung cancer (ES-SCLC) in combination with anlotinib and chemotherapy.
Phase III clinical trials have demonstrated that the combination therapy of benmelstobart with anlotinib and chemotherapy results in a median progression-free survival (mPFS) of 6.9 months and a median overall survival (mOS) of 19.3 months, significantly improving outcomes compared to chemotherapy alone.
Anlotinib, an oral multi-target kinase inhibitor, received marketing approval in China in May 2018 for the treatment of previously treated advanced non-small cell lung cancer (NSCLC). It has since received additional approvals for soft tissue sarcoma, SCLC, medullary thyroid carcinoma, and differentiated thyroid carcinoma. This latest approval marks anlotinib’s sixth indication and its first first-line lung cancer indication in China.
Furthermore, the benmelstobart/anlotinib combination is under review by the NMPA for the treatment of recurrent or metastatic endometrial cancer (EC), having been granted priority review and breakthrough therapy designations.- Flcube.com
