Apollomics announces approval of vebreltinib in China

Apollomics announced that its partner in China, Avistone Biotechnology, received approval from the National Medical Products Administration, NMPA, of China for vebreltinib, APL-101, for the treatment of adult patients with isocitrate dehydrogenase, IDH, mutant astrocytoma or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion gene and have failed previous treatments. This supplemental New Drug Application, sNDA, approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System, CNS, tumor with c-Met alteration, and follows the NMPA’s November 2023 approval of vebreltinib for the treatment of patients with Met Exon 14 skipping non-small cell lung cancer, NSCLC. “The NMPA’s approval of vebreltinib in gliomas is an important, first-in-class approval as it demonstrates vebreltinib’s CNS penetration ability and c-Met inhibitory activity in the tumors there,” said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics. “Our collaboration with Avistone, which includes data-sharing, and our ongoing global SPARTA trial with vebreltinib underscores our commitment and the potential to develop vebreltinib for treating patients with solid tumors with c-Met alterations globally, outside of China.”