Summary
- Johnson & Johnson obtained FDA approval for Erleada plus androgen deprivation therapy to treat patients with metastatic castration-sensitive prostate cancer.
- FDA approval of Erleada was based on of the phase 3 TITAN study in which there was a statistically significant improvement in terms of overall survival and radiographic progression-free survival.
- Erleada in the U.S. gained some market share in the most recent second quarter; however, still lags behind Xtandi, which is a major rival.
- The other prostate cancer drug Zytiga has been performing well for the company, generating $698 million in worldwide sales in Q2 of 2019.
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Johnson & Johnson (JNJ) announced that it had obtained FDA approval for its prostate cancer drug known as Erleada. This will allow the company to target more of the metastatic prostate cancer market. However, it's been having trouble competing against Pfizer (PFE) and Astellas in other indications for those with prostate cancer. However, patients with metastatic castration-sensitive prostate cancer had greatly benefited from treatment with Erleada. Especially, when you consider that, at the beginning of the year, a phase 3 study was stopped early due to highly positive efficacy. While Johnson & Johnson has a major competitor for its drug Erleada, this approval is a win nonetheless. Plus, it also had another prostate cancer drug known as Zytiga, which has been performing well.
FDA Supplemental Approval Adds To Erleada's Target Indications
The FDA approved the supplemental new drug application (sNDA) for Erleada along with androgen deprivation therapy (ADT). This is an important approval, because it will target a population that really needs additional treatment options. This is the case for two big reasons. The first is that when a cancer is in the metastatic state, that means it has spread to other organs in the body. Therefore, metastatic prostate cancer is a lot more difficult treat, compared to when it is just localized in the prostate. The second big reason is because these are patients who are castration-sensitive (also known as hormone-sensitive). This is important, because when a patient is castration-sensitive, it indicates that the use of androgen deprivation therapy alone is not able to stop androgen hormones (testosterone) from continuing to advance. The goal of ADT is to reduce these hormones, which in turn should theoretically help to stop the spread of the cancer. Unfortunately, in mCSPC, ADT is not enough to stop the spread of cancer alone. As I alluded to above, patients still partially respond to treatment of ADT when they are castration-sensitive, just not enough for the single treatment alone to overcome the hurdle of helping patients. Having said that, the addition of Erleada plus ADT was highly substantial in terms of achieving efficacy. That's because not only was the study stopped early, but it was recommended that those in the placebo arm move over to the drug arm of the study (Erleada plus ADT). Then, Johnson & Johnson can make the claim that its phase 3 registrational study is the first to achieve statistically significant data in dual primary endpoints of overall survival (OS) and radiographic progression-free survival (PFS) in patients with mCSPC regardless of the extent of disease. The trial was known as the phase 3 TITAN study. This phase 3 study recruited a total of 1,052 patients who were randomized to receive either ERLEADA plus ADT or placebo plus ADT. In terms of overall survival, those who were treated with Erleada plus ADT reduced the risk of death by 33%. This was statistically significant with a p-value of p = 0.0053. The other endpoint involving radiographic progression-free survival (rPFS) also did well. It was shown that the treatment arm reduced the risk of radiographic progression or death by 52%. This was achieved with a statistically significant p-value of p<0.0001. I would like to point out why this study was important in terms of clinical success. Besides the study being stopped early, there was a mix of patient populations. By that, I mean there were some mCSPC patients who were newly diagnosed (treatment naive), low volume disease, high volume disease, and those who had already received local therapy or six cycles of chemotherapy (docetaxel).
