The US FDA has accepted for review the filing of an sNDA for Astellas and Pfizer’s Xtandi.
The filing is to add an indication for the treatment of men with mHSPC, & has also been granted Priority Review if US FDA approved these drugs, may offer significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.
Back in this year i.e. in February 2019, companies revealed the results from Phase III ARCHES trial in men with mHSPC, the outcome was that the drug has significantly improved radiographic progression-free survival, which covers the way for the application to expand the drug’s use.
The results, which are for the drug in combination with androgen deprivation therapy, showed a significant reduction in the risk of radiographic progression or death by 60.9%, thus meeting the trial’s primary endpoint.
Additionally, the sNDA submission is supported by data from ENZAMET, an Astellas-supported, investigator-sponsored Phase III research study which met its primary endpoint of OS.
Pfizer’s Chris Boshoff, chief development officer, Oncology said: “pleased to receive the Priority Review designation, which reflects the need for more treatment options for men living with metastatic hormone-sensitive prostate cancer”.
Chris continued, “The submission of the file is supported by a strong data package, including two Phase III trials investigating XTANDI in men living with this form of prostate cancer.”
Xtandi is currently approved in the US & Japan for the treatment of CRPC & in the EU for advanced and high-risk non-metastatic CRPC.