The US Food and Drug Administration (FDA) has granted priority review status to the submission by pharmaceutical partners Pfizer (NYSE: PFE) and Astellas (TYO: 4503) for their drug combination of Xtandi (enzalutamide) and leuprolide. This treatment is intended for patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) who are at high risk of biochemical recurrence (BCR). The FDA anticipates making a decision on the treatment during the fourth quarter of 2023. This expedited review process is facilitated by Project Orbis, an initiative that enables concurrent submission and review of oncology drugs by international regulatory partners.
Phase III Data Supports Filing, Demonstrating Reduced Risk of Metastasis or Death
The filing for Xtandi in combination with leuprolide is supported by robust Phase III clinical trial data. These data indicate that the addition of Xtandi to leuprolide therapy reduced the risk of metastasis or death by 58% in patients with nmCSPC. Moreover, the safety profile of the combined treatment was found to be consistent with that of each individual molecule, providing confidence in the tolerability of the therapy.-Fineline Info & Tech
