Xtandi Gets FDA Second Cancer Therapy Approval

Drug from Pfizer and Astellas will compete with J&J’s Erleada as a treatment for early-stage prostate cancer.

Xtandi (enzalutamide) is a nonsteroidal antiandrogen medication is currently used in conjunction with castration for the treatment of metastatic castration-resistant prostate cancer, advanced prostate cancer that no longer responds to medical or surgical treatment. Pfizer and Astellas recently received a second approval from the US Food and Drug Administration (FDA) for Xtandi in the treatment of nonmetastatic prostate cancer (prostate cancer that has not yet spread through the body). 

This approval is important for the success of the drug and likely means it will reach blockbuster status, despite competition from Erleada (apalutamide) from Johnson & Johnson, which received FDA approval in February 2018—several months earlier than expected. In their respective clinical trials (Prosper and Spartan for Xtandi and Erleada) the two drugs exhibited essential equal performance with respect to delay of the spread of cancer.

Xtandi brought in $2.59 billion for Astellas and Pfizer in 2017, and market research firm EvaluatePharma predicts it will rake in $4.71 billion in 2022, making one of the top 15 best-selling cancer drugs in that year. The added revenue is important because Xtandi’s growth began to slow last year. Erleada is predicted by Barclays to peak at $1.3 billion in annual sales.

Xtandi is also in clinical trials for hormone-sensitive disease that has and has not yet metastasized and under study in additional subpopulations that could expand its market.


Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.