Swiss pharmaceutical giant Roche (SWX: ROG) has received priority review status from China’s Center for Drug Evaluation (CDE) for its investigational drug inavolisib (GDC-0077), a phosphatidylinositol-3 kinase α (PI3Kα) inhibitor. The drug is being evaluated for the treatment of PIK3CA-mutated, hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer. Inavolisib is set to be used in combination with palbociclib and endocrine therapy for this indication, potentially offering a new treatment option for patients in China.
Inavolisib’s priority review follows an earlier breakthrough therapy designation (BTD), underlining its potential to address a significant unmet medical need. The drug has shown a strong therapeutic signal in multiple epithelial tumor indications, particularly among patients with non-small cell lung cancer, small-cell lung cancer, nasopharyngeal cancer, esophageal squamous cell carcinoma (ESCC), and breast cancer.
On the same day, inavolisib was also awarded breakthrough therapy designation for the treatment of recurrent or metastatic nasopharyngeal carcinoma that has previously been treated with PD-1/PD-L1 monoclonal antibody and has failed at least two lines of chemotherapy. This adds to the drug’s potential impact on cancer treatment in China, where other PI3K inhibitors targeting PI3Kδ, such as CSPC’s in-licensed Copiktra (duvelisib) and Yingli Pharma’s linperlisib, are also in the market or under clinical research .- Flcube.com
