Pfizer stated that the FDA has assigned the priority review status of the application for the PARP inhibitor talazoparib use in patients with metastatic breast cancer and a hereditary mutation of the BRCA gene.
According to information from the company, EMA also accepted an application for talazoparib from this group of patients.
Metastatic breast cancer is a type of breast cancer in which the disease has spread to other organs. This type refers to the 4 stages of cancer or to progressive cancer, which develops if treatment of the primary cancer stages was not successful.
Breast cancer spreads when cancer cells enter the nearby healthy cells and self-reproduce, spreading throughout the body through the bloodstream, and through the capillaries move to neighboring tissues, form new tumors in other parts of the body.
Pfizer obtained the rights to talazoparib as a result of the acquisition of Medivation for $ 14 billion.
Applications in the US and Europe were submitted based on the EMBRACA Phase III clinical trial showing significant superiority to talazoparib for progression-free survival (PFS) versus placebo. The median value of PFS was 8.6 months. in the group with talazoparib and 5.6 months. in the group of patients receiving chemotherapy. In general, the risk of disease progression decreased by 46%.