The 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics, predicted approval and market entry of Johnson & Johnson’s Erleada (apalutamide), the first FDA-approved treatment for non-metastatic castration-resistant prostate cancer (CRPC).1,2 This approval came two months ahead of its April 2018 PDUFA date and only four months after its new drug application (NDA) filing in October 2017, which had been granted Priority Review.3 Marketing authorization applications for non-metastatic CRPC were submitted in the EU in February 2018 and in Japan in March.4,5
Prostate cancer is the most common cancer in the U.S. and the third most common cause of cancer death in U.S. men. More than 164,000 men will be diagnosed with prostate cancer in 2018 and about one man in 41 will die of prostate cancer.6
Male sex hormones, known as androgens, are required for normal growth and function of the prostate. Androgens are also necessary for prostate cancers to grow. Hormone therapy for prostate cancer—also called androgen suppression therapy or androgen deprivation therapy—can block the production and use of androgens. When the prostate cancer continues to progress despite androgen deprivation, the disease is considered to be castration resistant.7
Prior to the February U.S. approval of Erleada, no FDA-approved treatment options were available for men with non-metastatic CRPC until metastasis could be confirmed by radiographic assessment.”
The CRPC market is dominated by the oral next-generation anti-androgens Zytiga (abiraterone; also from Johnson & Johnson) and Xtandi (enzalutamide; Pfizer/Astellas), which are both approved for metastatic CRPC .8,9 Prior to the February U.S. approval of Erleada, no FDA-approved treatment options were available for men with non-metastatic CRPC until metastasis could be confirmed by radiographic assessment. Although Xtandi was subsequently approved for the treatment of non-metastatic CRPC in July 2018, Erleada has gained first-mover advantage, having been launched in February shortly after approval.2,10
The NDA submission for Erleada was based on data from the pivotal phase 3 SPARTAN trial. Trial results showed that the drug significantly extended metastasis-free survival by 24.3 months compared with placebo, with a 72% reduction in risk of distant metastasis or death.11 Xtandi demonstrated similar effects in non-metastatic CRPC in the PROSPER trial, with an increase in metastasis-free survival of 21.9 months and a 71% reduction in the risk of developing metastases or death.12
Erleada also has potential applications in other clinical settings, including metastatic hormone-sensitive prostate cancer (assessed in the TITAN trial13), in high-risk localized/locally advanced prostate cancer (assessed in the ATLAS trial14), and in combination with Zytiga for treatment of metastatic CRPC in men who have not yet received chemotherapy, which are contributing to its blockbuster potential.15
Cortellis Consensus Sales Forecasts (source Thomson Reuters I/B/E/S) for Erleada have decreased since the Drugs to Watch 2018 report was published, from $2.000 billion for 2022 to $1.576 billion for 2022, likely because of increased competition from Xtandi in the non-metastatic CRPC setting. See figure 1 for projected sales at the time of the Drugs to Watch 2018 report’s release.
Figure 1: . Cortellis Consensus Sales Forecasts for Erleada have decreased since the Drugs to Watch 2018 report was published, from $2.000 billion for 2022 to $1.576 billion for 2022. Source: Thomson Reuters I/B/E/S.
This article is part of an ongoing blog series profiling the 12 new, game-changing drugs predicted to achieve blockbuster status by 2022 in the 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics. Read the full Drugs to Watch report here or follow the series for the latest updates.