Newswire (Published: Friday, August 23, 2019, 9:31:00 AM CDT, Received: Friday, August 23, 2019, 10:05:20 AM CDT)

Word Count: 274

The FDA has granted a priority review to a supplemental New Drug Application (sNDA) for a new indication for enzalutamide (Xtandi) as a treatment for men with metastatic hormone-sensitive prostate cancer (mHSPC).1

The sNDA is supported by findings from the phase III ARCHES trial as well as data from the phase III ENZAMET trial, both of which demonstrated improved outcomes for patients with the use of enzalutamide. The FDA has set a target action date for a decision on the sNDA by the fourth quarter of 2019.

We are pleased to receive the Priority Review designation, which reflects the need for more treatment options for men living with metastatic hormone-sensitive prostate cancer, said Chris Boshoff, MD, PhD, chief development officer of oncology, Pfizer Global Product Development, in a press release. Pfizer and Astellas Pharma are jointly developing and commercializing the androgen receptor inhibitor. The submission is supported by a strong data package, including 2 phase III trials investigating Xtandi in men living with this form of prostate cancer.

The international, double-blind ARCHES trial explored the addition of enzalutamide to androgen deprivation therapy (ADT) compared with ADT alone in men with mHSPC. The trial enrolled 1150 men with mHSPC who were randomized 1:1 to receive either 160 mg/day of enzalutamide or placebo plus ADT.2

The primary endpoint of radiographic progression-free survival (PFS) was met, showing a 61% reduction in the risk of radiographic progression or death with the addition of enzalutamide. At a median follow-up of 14.4 months, the median rPFS was not reached in the enzalutamide arm compared with 19.0 months in the ADT and placebo arm (HR, 0.39; 95% CI, 0.30-0.50; P

Companies

Pfizer Inc.
Astellas Pharma Inc.
Astellas Pharma Inc.
Arches Holdings Limited

Industries

Pharmaceuticals

Subjects

Health and Wellness
      Medical Conditions and Diseases
            Cancer
                  Prostate Cancer
            Men's Health Issues
                  Prostate Cancer
      Medical and Pharmaceutical Regulation
            Drug and Device Approval Process
                  Drug Testing and Approval Process
                        FDA Drug Approval
                  FDA Fast Track Designation
      Treatments and Therapies
            Medicinal Drugs
                  Drug Testing and Approval Process
                        FDA Drug Approval
Trading Impact
      Drug and Device Regulatory Impact
            FDA Fast Track Designation
Politics and Government
      Government Regulation