Pfizer and Astellas are celebrating the positive topline Phase III results for Xtandi (enzalutamide) announced on Thursday, raising hopes of adding another indication to the jointly marketed prostate cancer drug.
Xtandi has been approved to treat three different kinds of prostate cancer, including metastatic and non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. This innovative treatment has the potential to drastically improve the lives of those affected by these types of prostate cancer.
A new study has revealed an exciting advancement in the treatment of non-metastatic castration-sensitive prostate cancer (nmCSPC) in men: the combination of Xtandi plus leuprolide, a gonadotropin-releasing hormone agonist, showed a significant improvement in metastasis-free survival (MFS) compared to placebo plus leuprolide. This breakthrough has the potential to greatly improve the lives of many nmCSPC patients.
Xtandi provided statistically significant improvement in patient MFS when used as a monotherapy against leuprolide, and early data suggests that this benefit may be further enhanced when used in combination with other therapies. While full data is not yet available, the combo arm appears to yield further survival benefits.
The participants in this trial were men facing a high risk of biochemical recurrence, making it an especially important trial to observe.
Prostate cancer is the most common cancer among American men after skin cancer, and the second leading cause of cancer death. Unfortunately, it has the potential to spread quickly and affect up to half of the 1 in 8 men who are diagnosed. It’s a slow-growing cancer, but it’s important to be aware of the risks and take the necessary steps to protect your health.
Xtandi, the only novel hormone therapy approved for three states of prostate cancer, is set to expand its indications. Pfizer and Astellas are presenting data from a Phase III trial to the FDA in hopes of adding the nmCSPC indication to the list. If approved, this would be a major milestone in the treatment of prostate cancer.
In January 2023, Sen. Elizabeth Warren sparked controversy when she requested that the U.S. government exercise march-in rights for the pricey Xtandi drug. This was due to the fact that the NIH had granted roughly half a million dollars in grants to the drug’s development. Unfortunately, not a single request for the government to exercise march-in rights has been granted yet.
The U.S. cost of the drug per patient can be staggering, with a hefty annual price tag of approximately $189,000, far surpassing the price of the same drug in Europe and other countries. But some have noted that over the years, the net cost of the drug has been slowly decreasing.
Sen. Elizabeth Warren has highlighted an alarming trend in the healthcare system: a rise in gross prices in order to provide discounts. Wayne Winegarden, Ph.D., senior fellow at the Pacific Research Institute, agrees that this is a sign of a messed up system. He has noted the necessity to take a closer look at the pricing structure of healthcare and the potential for a more equitable and affordable system.
A real-world trial between Johnson & Johnson’s oral anti-androgen drug Erleada and Xtandi found that Erleada had a greater early impact on reducing prostate-specific antigen levels from baseline. This result suggests Erleada could be an effective treatment for prostate cancer.
J&J’s drug Erleada is showing strong sales, having made $1.340 B globally in the first nine months of 2022. It is currently only approved to treat two types of prostate cancer, but its success may indicate a larger role for Erleada in the future.