China’s Center for Drug Evaluation (CDE) has indicated that Beijing Pearl Biotechnology Co., Ltd’s breatinib has obtained priority review status for the treatment of WHO grade 4 astrocytoma with isocitrate dehydrogenase (IDH) mutation and PTPRZ1-MET (ZM) fusion gene, or adult glioblastoma (GBM) patients who have relapsed after, or become intolerant to, radiotherapy and temozolomide (TMZ) treatment.
Priority Review and Clinical Need
The priority status reflects the drug’s classification as an in-shortage, urgently clinically needed therapy, and its recognition as an innovative drug for rare diseases. This designation is expected to expedite the regulatory review process, bringing the therapy closer to patients in need.
Breatinib Development and Efficacy
Breatinib, a Category 1b c-MET inhibitor originated by Crown Bioscience and co-developed by its spin-off Apollomics Inc. and Pearl Bio, has demonstrated good tolerability and the ability to penetrate the blood-brain barrier in Phase I clinical studies. Previously, it was awarded priority review status and breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with mesenchymal epithelial transition factor (MET) exon 14 mutation.-Fineline Info & Tech
