The FDA has approved a priority review for Zytiga use pre chemotherapy, expediting the process to 6 months from submission. The sNDA filing was made on June 16th so we should hear a decision by the 16th of December this year. The usual process takes up to 12 months for review of NDA applications but priority review status was approved by the FDA taking into account the unmet clinical needs of patients who have relapsed following androgen deprivation therapy before they need to receive chemotherapy. The submission was based on the phase 3 clinical trial data which showed positive results for Zytiga in the prechemotherapy setting.
No comments:
Post a Comment