Summary
- The FDA has accepted review of the sNDA for Xtandi to treat patients with metastatic hormone-sensitive prostate cancer.
- Xtandi was given Priority Review by the FDA for the treatment of metastatic hormone sensitive prostate cancer patients, which will cut review time from 10 months down to 6 months.
- In Q2 2019 sales of Xtandi reached $201 million compared to $171 million in the same time period in 2018, which was year over year growth of 18%.
- Pfizer is looking to further expand the label for Xtandi, with the next target being to go after non-metastatic hormone-sensitive prostate cancer patients.
- I do much more than just articles at Biotech Analysis Central: Members get access to model portfolios, regular updates, a chat room, and more. Get started today »
Pfizer (PFE) and its partner Astellas have announced that the FDA has accepted the review of the supplemental New Drug Application ((sNDA)) to expand the label for Xtandi. This expanded approval is for metastatic hormone-sensitive prostate cancer. The drug has already been approved in the United States to treat castration-resistant prostate cancer. Not only was the sNDA accepted, but it was accepted as a Priority Review. This newly expanded label, should it be approved, would allow for both companies to expand upon the current market opportunity that exists for Xtandi.
Accepted Review To Be Done In Shorter Period
The sNDA being accepted is the first step for Pfizer and its partner Astellas to gain approval for metastatic hormone-sensitive prostate cancer. The first thing to note right away is the significance of gaining Priority Review. This is crucial, because this designation is only given if it is believed that regulatory approval for Xtandi in this indication would be significantly superior over currently available therapies. Such available options are standard of care (SOC) treatments used for the time being. This designation alone doesn't guarantee an expanded label, but it does improve the odds in my opinion. The reason for filing the sNDA is because of positive results from two late-stage studies. These two studies are ARCHES and ENZAMET respectively. As I highlighted above, Xtandi was already approved for castration-resistant prostate cancer. The goal is to expand the label to this new indication. For instance, if you look at the phase 3 ARCHES study you can understand why the FDA gave Xtandi Priority Review for this indication. This particular phase 3 study recruited a total of 1,150 men with metastatic hormone-sensitive prostate cancer. Patients were randomized 1:1 to receive either Xtandi at 160 mg plus androgen deprivation therapy (ADT) or placebo plus ADT. The final conclusion was that patients who took Xtandi on top of ADT saw a 61% reduction in disease progression or death. Based on this number, you can understand why the FDA would be enticed to get this drug out to patients as quickly as possible. That's exactly what a Priority Review is going to do. A Priority Review brings down the amount of time for a given review from 10 months (typical review time period after FDA regulatory filing) down to only 6 months. Even then, there are instances where the FDA may decide to approve a drug earlier than the 6 month period. The 6 months is just the maximum amount of time, but if possible it can approve the drug much quicker than anticipated.
