The National Medical Products Administration (NMPA) of China granted conditional approval to biotech Apollomics for the commercialisation of its non-small cell lung cancer (NSCLC) treatment.
Velbretinib (APL-101) is an orally bioavailable small molecule that treats NSCLC patients with MET exon 14 skipping alterations by inhibiting c-Met. This is a protein that is key in the tumour growth pathway. MET exon 14 skipping mutations occur in approximately 3% of cases of NSCLC. This condition is most diagnosed in adults aged over 70 with a smoking history.
China’s NMPA grants conditional approvals to treatments for diseases that are severely life-threatening and there is no effective treatment method. Under the terms of an agreement, the company’s Chinese partner, Avistone, holds the drug’s exclusive rights in China, Hong Kong and Macau. Apollomics holds the rights for the US and all other countries.
California-headquartered Apollomics is also in active discussions with the US Food and Drug Administration (FDA) pursuing a US approval, as per a 16 November press release. This will be based on clinical data from the Phase II multi-cohort SPARTA trial (NCT03175224) and Avistone Biotechnology’s Phase II KUNPENG trial (NCT04258033) in China.
Apollomics recently announced the expansion of the SPARTA Phase II study to include patients with EGFR-mutated NSCLC and the addition of an extra cohort to study the velbretinib monotherapy in histology-agnostic solid tumours with wild-type MET gene that have high expression of c-MET and hepatocyte growth factor. The Washington University School of Medicine is also evaluating the safety and efficacy of combining velbretinib with AstraZeneca’s Tagrisso (osimertinib) in patients with epidermal growth factor receptor (EGFR)-mutated NSCLC in a separate Phase I/II study.
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In an October 31 press release, Apollomics’s CEO Dr Guo-Liang Yu said: “The NMPA approval of velbretinib is an important milestone toward providing a new treatment option for patients with MET exon 14 skipping NSCLC in China. Apollomics extends its full support and congratulations to Avistone on this significant achievement.”