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Enzalutamide (Xtandi) Set to Become No. 1 Prostate Cancer Treatment, Survey Finds

Prevention of castrate-resistant or metastatic disease remains key unmet need

Decision Resources Group, a health care research firm located in Burlington, Mass., finds that enzalutamide (Xtandi, Astellas/Medivation) will be the sales-leading agent across the world’s major markets for prostate cancer, garnering $3.4 billion in 2023.

This growth in sales will be driven primarily by the uptake of enzalutamide as a first-line treatment for chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) — a setting in which the drug will compete directly with the first-to-market hormonal agent abiraterone acetate (Zytiga, Janssen Biotech).

In addition, the anticipated extension of enzalutamide for the untapped nonmetastatic castrate-resistant prostate cancer (nmCRPC) setting will contribute to nearly one third of its major-market sales in 2023 in the U.S, Europe, and Japan, the report says.

“Now that the mCRPC segment is crowded, drug developers are increasingly shifting their focus on the untapped and potentially lucrative nmCRPC segment,” analyst Khurram Nawaz, MSc, remarked. “The lack of therapies specifically approved for nmCRPC opens doors for new agents that can demonstrate clinically significant outcomes in delaying metastatic progression.”

The report predicts that major-market sales of prostate cancer therapies will grow from $4.4 billion in 2013 to $9.3 billion in 2023, driven by the continued uptake and line extensions of enzalutamide, by the uptake of radium Ra 223 dichloride injection (Xofigo, Bayer HealthCare), and by the expected launch of three high-priced emerging therapies.

Moreover, two novel androgen receptor inhibitors ––ARN-509 (Johnson & Johnson) and ODM-201 (Orion/Bayer HealthCare) –– are expected to enter the underserved nmCRPC setting after enzalutamide. Taken together, ARN-509 and ODM-201 are predicted to capture combined sales of $1.4 billion in 2023 across the major markets.

Abiraterone was the sales-leading prostate cancer agent in 2013 across the major markets. However, the anticipated entry of less costly generic versions of the drug during the forecast period will erode sales in the U.S. and Europe. As a result, major-market sales of branded abiraterone are expected to drop to less than $600 million in 2023.

 “Several unmet needs remain unaddressed in prostate cancer, most urgently the lack of clarity on how to sequence recently approved agents in clinical practice,” Nawaz said. “Interviewed experts also cite the need to prevent or delay development of castrate-resistant disease and metastatic disease as important unmet needs.”

Source: Decision Resources Group; October 30, 2014.

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