Chia Tai Tianqing, a renowned biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted for review a new indication filing for its anlotinib (trade name: FOCUS V) in combination with the anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The proposed indication is for the treatment of recurrent or metastatic endometrial cancer (EC) in patients with non-microsatellite instability-high (non-MSI-H) or non-DNA mismatch repair (non-dMMR) who have previously failed or are intolerable to first-line or second-line chemotherapy regimens.
Anlotinib, an oral multi-target kinase inhibitor, targets VEGFR, PDGFR, FGFR, and c-Kit, exhibiting anti-angiogenic effects and inhibiting tumor growth. The drug received marketing approval in China for the treatment of previously treated advanced non-small cell lung cancer (NSCLC) in May 2018 and has since been approved for additional indications including soft tissue sarcoma, small cell lung cancer, medullary thyroid carcinoma, and differentiated thyroid carcinoma.
The combination therapy of anlotinib and benmelstobart, which is awaiting regulatory decisions in China for the treatment of first-line small cell lung cancer, was granted breakthrough therapy designation (BTD) and priority review statuses for the treatment of recurrent or metastatic endometrial cancer in April 2022 and January 2024, respectively.
This new filing acceptance by the CDE highlights Chia Tai Tianqing’s commitment to expanding the therapeutic potential of anlotinib and benmelstobart, offering hope to patients with endometrial cancer who have limited treatment options.- Flcube.com
