How Treatment Works

TALZENNA + XTANDI treats HRR gene-mutated mCRPC in 2 different ways.

HRR gene-mutated mCRPC = prostate cancer with certain abnormal inherited or acquired genes called homologous recombination repair (HRR genes) that has spread to other parts of the body (metastatic) and no longer responds to a hormone therapy or surgical treatment to lower testosterone (castration-resistant).

How TALZENNA Works

The short answer: TALZENNA may help inhibit cancer cells from repairing themselves, which could lead to even more cell damage that makes it harder for them to survive.

Here is a more in-depth explanation:

The DNA in the nucleus of your cells tells your body how to form and function. DNA is arranged in groupings called genes, which make proteins that drive this process. Importantly, DNA regulates the ability of cells to duplicate to keep the process going. But DNA can become damaged.

When there’s damaged DNA, called breaks in the DNA strands, proteins such as PARP,* which exist in your cells, help repair the breaks to keep the cells functioning. This occurs for both normal and cancerous cells.

^*PARP = poly (ADP-ribose) polymerase.

HRR provides another mechanism for DNA repair. In cells, there may be damage to HRR genes due to mutations. Mutated HRR genes prevent proteins associated with the pathway from being effective in DNA repair.

TALZENNA is for men whose prostate cancer has an HRR gene mutation. TALZENNA works by inhibiting the repair protein, PARP, from activating the cell's repair pathway. This, in combination with the dysfunction of the mutated HRR gene, makes it harder for cancer cells to survive.

TALZENNA can also affect normal cells, which can lead to side effects.

This is how TALZENNA was shown to work in laboratory studies. Clinical significance is unknown.

How XTANDI Works

XTANDI is an androgen receptor inhibitor.

Here is information about how this treatment works:

Androgens are a group of hormones that include testosterone. Androgen receptor inhibitors decrease how often androgens like testosterone connect with an androgen receptor, and thereby may slow the growth of prostate cancer tumors and cells. Let's take a look inside the cell.

When androgen connects with an androgen receptor, it may cause tumor cells to grow.

XTANDI helps decrease how often androgen can connect with an androgen receptor. As a result, XTANDI can slow cancer cell growth and the cancer cells may die.

This is how XTANDI was shown to work in laboratory studies. Clinical significance is unknown.

How to Take TALZENNA

• Take TALZENNA exactly as your healthcare provider tells you.
• Do not change your dose or stop taking TALZENNA without first talking with your healthcare provider.
• Take TALZENNA in combination with enzalutamide 1 time a day.
• You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with TALZENNA and enzalutamide unless you have had a surgery to lower the amount of testosterone in your body (surgical castration).
• Take TALZENNA with or without food.
• Swallow TALZENNA capsules whole. Do not dissolve or open TALZENNA capsules.
• Your healthcare provider may change your dose of TALZENNA or tell you to stop taking TALZENNA depending on how you respond to treatment.
• If you miss a dose of TALZENNA or vomit, take your next dose at your regular time. Do not take an extra dose to make up for a missed dose.
• If you take too much TALZENNA, call your healthcare provider or go to the nearest hospital emergency room right away.

Please talk to your doctor or see XTANDI Patient Information to learn how to take XTANDI.