All-round prostate cancer treatment Xtandi with solid growth

Blockbuster anticancer drug | Episode 8: Xtandi

Achieved 30 billion won in sales through rapid reimbursement listing… holds No. 1 market share for prostate cancer treatment

Zytiga catches up in the specified prostate cancer treatment environment… Whether Xtandi will be able to maintain its lead receives attention

Xtandi (enzalutamide)' rose to the ranks and became a blockbuster drug last year after continuously extending its indication in prostate cancer, a field that lacked treatment options.

 

Although the drug was approved later than its competitor, through its continuous expansion effort, Xtandi became the only single-agent drug that is approved for use in both metastatic and nonmetastatic prostate cancer.

 

Enzalutamide inhibits the AR signaling pathway by binding to the male hormone Androgen receptor (AR) to suppress the proliferation of cancer cells.

 

Although the drug was approved later than its competitors such as ‘Zytiga (Janssen)’ or ‘Jevtana (Sanofi),’ in June 2013, Xtandi was the first to be approved for reimbursement.

 

Xtandi was listed for reimbursement in November 2014 under the refund-type Risk-Sharing Agreement (RSA) scheme.

 

During the 3.5 years that other drugs it took for the other drugs to receive reimbursement, Xtandi gradually took over the market as a second-line treatment for metastatic castrate-resistant prostate cancer.

 

Xtandi sold over 10 billion to 20 billion in sales according to IQVIA from 2015 to 2017, when it was the only drug approved for reimbursement, while Zytiga sold 1 billion won and Jevtana 0.4-0.5 billion won in the same period.

 

The multinational pharmaceutical company Pfizer recognized the potential of Xtandi and added it to its portfolio through an M&A with its original developer, Medivation.

 

In Korea, Xtandi is continuously being supplied by Astellas, which had entered into a sales agreement with Medivation.

 

It is distributed by Pfizer and Astellas in the U.S.

 

◆Used for all castration-resistant prostate cancer regardless of metastasis…Rises to the rank as No.18 blockbuster drug Xtandi gradually expanded its indications from its first indication as second-line treatment for metastatic castration-resistant prostate cancer to first-line, then to non-metastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer.

 

Through its continuous expansion effort, Xtandi became the only single-agent drug that covers all metastatic and nonmetastatic, hormone-sensitive (castration-sensitive), and castration-resistant prostate cancer.

 

The NCCN recommends Xtandi as a first-line treatment in metastatic castration-resistant prostate cancer, and as Category 1 in metastatic hormone-sensitive prostate cancer.

 

With the recommendations, Xtandi has established its position as a leading prostate cancer treatment.

 

Source: IQVIA

In terms of domestic sales (based on IQVIA), Xtandi’s sales increased continuously since receiving reimbursement in November 2014 to record 13.9 billion won in 2015 to 18.8 billion won in 2016, 20 billion won in 2017 and 23.8 billion won in 2018.

 

It is the highest-grossing new prostate cancer drug.

 

It recorded the highest sales among new prostate cancer drugs.

 

Although its sales briefly slowed down to 23 billion won in 2019, it rebounded last year to record nearly 30 billion won.

 

Globally, Xtandi also outperformed the other drugs and rose to the ranks to become one of the top 20 blockbuster drugs for the first time last year.

 

Last year, Xtandi sold 4.39 billion dollars (approx.

 

5.19 trillion won) in global sales and became the 18th best-selling drug in the world.

 

Projected sales per Xtandi

Furthermore, Astellas expressed its ambition to maximize Xtandi’s sales over the next five years.

 

In the new strategic planning meeting that was held in May, Astellas projected that Xtandi will sell 600 billion to 700 billion yen (approx.

 

6.20 trillion-7.24 trillion won) at maximum by the fiscal year 2025 (March 2026).

 

Astellas also plans to extend the indication to high-risk non-metastatic hormone-sensitive prostate cancer next year.

 

◆The introduction of new latecomer drugs and Zytiga’s late but rapid chase … use of PARP inhibitors allows for more specified treatment strategies The competition in the prostate cancer treatment market is intensifying.

 

New drugs such as ‘Erleada (Janssen),’ ‘Nubeqa (Bayer)’ etc.

 

are continuing to be introduced while PARP inhibitors that target BRCA mutation like ‘Lynparza (AstraZeneca)’ is expanding their scope to cover prostate cancer as well.

 

Erleada is approved for non-metastatic hormone-sensitive and nonmetastatic castration-resistant prostate cancer in the US, and Nubeqa is approved for the high-risk nonmetastatic castration-resistant prostate cancer indication.

 

Also, a PARP inhibitor was recently approved for prostate cancer and settled as a new treatment strategy and option for castration-resistant prostate cancer patients with BRCA 1/2 and DNA Damage Response (DDR).

 

In particular, Lynparza in combination with Zytiga emerged as a stronger option by meeting the primary endpoint of radiological progression-free survival.

 

The Lynparza+Zytiga combination aims to become a first-line treatment for metastatic castration-resistant prostate cancer regardless of genetic mutations.

 

In Korea, the fact that Xtandi’s sales fell short in metastatic hormone-sensitive prostate cancer, which is the second-most on-demand area after metastatic castration-resistant prostate cancer, also leaves much to be desired in terms of expanding Xtandi sales.

 

Zytiga added the indication in June 2018, and the latecomer Erleada was also approved for the indication at the end of last year, Xtandi only received approval for the indication in September this year.

 

While Xtandi made no further progress since expanding reimbursement to first-line treatment in metastatic castration-resistant prostate cancer in May 2019, Zytiga persisted on the path to be approved for selective reimbursement in high-risk groups among metastatic hormone-sensitive prostate cancer patients in April this year.

 

Although Xtandi was approved for both the high-risk and low-risk groups, Zytiga, which received limited approval for the high-risk group, holds the immediate upper hand in prescriptions.

 

After the reimbursement expansion, Zytiga’s quarterly sales surged from 2 billion won to approximately 4 billion won.

 

In response, Astellas is seeking a way to extend its indication and expand reimbursement of Xtandi from the current metastatic hormone-sensitive indication to cover all patients.

 

In addition, the company is seeking a new treatment strategy through a clinical trial in combination with Pfizer’s PARP inhibitor ‘Talzenna.’ The clinical trial is expected to end in three years.

 

Astella said, “We expect sales of Xtandi is to continue to grow due to its competitive price and the yearly increase of prostate cancer, the fourth most common cancer in men.

 

Depending on the domestic situation, we are also considering adding further indications, and are planning to expand reimbursement to the treatment of metastatic hormone-sensitive prostate cancer regardless of the degree of risk.”