Update: News from the FDA: First-line treatment and biosimilars for prostate cancer

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Research Timeline: Post Approval

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New drug approval for Xtandi

On November 16, 2023, the Food and Drug Administration (FDA) approved Xtandi (enzalutamide) for people with non-metastatic castration-sensitive prostate cancer (CSPC) that still responds to hormone therapy whose prostate serum antigen (PSA) levels have risen after treatment. 

Xtandi is a type of medication called an androgen receptor inhibitor, which stops the growth of cancer cells by blocking the effects of androgens (a male reproductive hormone). It is a pill that can be taken at home.

Xtandi was previously approved for the treatment of metastatic and non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.

Why is this update important?

People with CSPC whose PSA levels have risen rapidly after treatment have a high risk for metastasis. For these patients, the latest approval of Xtandi is a promising treatment option.

FDA approves two new bone-strengthening drugs

The FDA approved two new bone-strengthening drugs: Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz) that may be used as part of prostate cancer treatment. They belong to a group of drugs known as biosimilars. They may provide less expensive options to currently available bone-strengthening drugs. However, these drugs are not yet available in the United States. The anticipated date of availability is May 31, 2025.

Why is this update important?

For patients with prostate cancer, bone health is impacted both by the disease and its treatment.

• When prostate cancer spreads beyond the prostate, it often travels to the bone. This can cause pain, fractures and spinal cord compression.
• Treatments such as androgen deprivation therapy (ADT) can also cause bone loss, which leads to osteoporosis and related complications.

Both of these scenarios are a major cause of reduced quality of life for people with prostate cancer.

You can read more about bone-protecting drugs for prostate cancer here.

What are the new drugs Jubbonti and Wyont?

Jubbonti and Wyost are bone-strengthening drugs. They are biosimilars, which means they work similarly to already-approved bone-strengthening drugs. 

• Jubbonti (denosumab-bbdz) was approved as an interchangeable biosimilar to the drug Prolia (denosumab).
• Wyost (denosumab-bbdz) was approved as an interchangeable biosimilar to the drug Xgeva (denosumab).

Jubbonti and Wyost are the first interchangeable biosimilars for bone-strengthening biologic drugs.  These biosimilars work like biologic drugs; they prevent bone cells from breaking down in the body.

For cancer patients, Jubboniti is approved for:

• increasing bone mass in people at high risk for a fracture who are taking androgen deprivation therapy for nonmetastatic prostate cancer.
• increasing bone mass in people at high risk for a fracture who are taking aromatase inhibitor therapy for breast cancer.

For cancer patients, Wyost is approved for:

• patients with bone metastases from solid tumors.

Cost

• The list price for Prolia is $1,786/injection taken every 6 months. This will likely vary depending on your insurance.
• The list price for Xgeva is $3,285/injection taken every 4 weeks. This will likely vary depending on your insurance.
• List prices for Jubbonti and Wyost have not yet been determined.  These drugs are not yet available in the U.S. 

Are biosimilars safe?

A biosimilar drug is nearly identical to an original biologic drug. Both biosimilar drugs and biologic drugs are made in living cells such as yeast, bacteria or animal cells.

The FDA has strict rules that must be met before a biosimilar drug is approved. Before approval, a biosimilar must be shown in clinical trials to be as safe and effective as its brand-name biologic.

Biologics are often very expensive because of the high cost to study and make them. Biosimilars usually cost less than brand-name biologics. Approval of biosimilars can lead to increased competition and lower prices.

Some insurance companies may cover the cost or part of the cost of a biosimilar, while others may not. If a biosimilar is an option for you, it is important to discuss your coverage with your insurance company.

What do these updates mean for me?

If you have been diagnosed with castration-sensitive prostate cancer and your PSA tests are rising,  Xtandi may be a treatment option for you.

If you have prostate cancer that has spread to your bone or if you are on hormone therapy that is known to weaken the bones, the approved biosimilars, once they are available in the United States, may be a less expensive option for protecting your bone health.

The actual price you’ll pay for either drug depends on your insurance plan, your location and the medical office where you receive each drug.

Reference

FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence. FDA news release. November 17, 2023.

FDA approves first interchangeable biosimilars for Prolia and Xgeva to treat certain types of osteoporosis and cancer. FDA news release. March 5, 2024.

Additional information:

To read more of FORCE’s XRAY reviews on prostate cancer click this link.

The FDA provides a podcast series called Drug Information Soundcast in Clinical Oncology (DISCO), offering up-to-date information on new product approvals, emerging safety information for cancer treatments and other current topics in cancer drug development. Listen on Apple Podcasts, Google Podcasts or Spotify. 

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

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posted 9/10/24