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WHAT IS TALZENNA?

TALZENNA is a prescription medicine used to treat adults with a certain type of breast cancer (gBRCA-mutated, HER2-) that has spread to other parts of the body (locally advanced or metastatic). Your healthcare provider will perform a test to make sure that TALZENNA is right for you. It is not known if TALZENNA is safe and effective in children.

TALZENNA is a once-daily oral treatment. Refer to STARTING AND TAKING TALZENNA for more information.

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Clinical Study Results

TALZENNA was studied in a clinical trial of 431 patients with gBRCA-mutated, human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/MBC) who had previously received up to 3 rounds of chemotherapy and no previous PARP inhibitor therapy. Patients in the trial had either hormone receptor-positive (HR+), HER2- breast cancer, or triple-negative breast cancer (TNBC).

Patients were split into 2 groups. The first group (287 patients) received TALZENNA, while the second group (144 patients) received their healthcare provider’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine).

TALZENNA was significantly more effective at delaying disease progression than chemotherapy.

In this clinical trial, disease progression was delayed for a median of 8.6 months in patients taking TALZENNA, which means their tumors did not grow or spread in that time, compared to 5.6 months for patients taking chemotherapy.

Delaying disease progression

TALZENNA reduced the risk of cancer growing, spreading, or getting worse by 46% vs chemotherapy.

Progression was seen in 185 (65%) of patients on TALZENNA and 83 (58%) of patients on chemotherapy.

This study also measured the total time patients on each medicine remained alive after starting treatment (overall survival). There was no significant difference in overall survival between the patients taking TALZENNA and the patients taking chemotherapy.

In the same clinical trial, tumor response to treatment was measured. The results showed that in patients who received TALZENNA, tumor response was 50.2%—meaning half (110 of 219) of patients saw their tumors shrink in size—compared to 18.4% (21 of 114) for patients who received chemotherapy. The percentage of patients who saw their tumors shrink was over 2X higher for TALZENNA vs chemotherapy.

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Tumor Response = Complete Response + Partial Response

Complete Response

All signs of cancer disappear, but this does not mean that the cancer is cured. 5.5% of patients taking TALZENNA VS 0% of the patients taking chemotherapy

Partial Response

Tumors that shrink by 30% or more. 44.7% of patients taking TALZENNA VS 18.4% of the patients taking chemotherapy

The length of time the tumor response lasted before the tumors resumed growing or spreading was a median time periodMedian Time Period In a cancer treatment study, median time period of tumor response means that half of the patients responded to a treatment for at least a specific amount of time and half responded for less than that specific amount of time. of 6.4 months in patients taking TALZENNA and a median time periodMedian Time Period In a cancer treatment study, median time period of tumor response means that half of the patients responded to a treatment for at least a specific amount of time and half responded for less than that specific amount of time. of 3.9 months in patients taking chemotherapy.

How Talzenna Works In Cells

When DNA within a cell becomes damaged, the BRCA proteins work along with other DNA-repair proteins to help repair damaged DNA. When cells have a gBRCA mutation, the cells cannot repair their DNA normally—and this can sometimes cause cancer to form. Because these cancer cells have defective BRCA proteins to repair their DNA, the cells rely on other DNA-repair proteins, like PARP, to keep the cancer alive. Treatments that block PARP, also called PARP inhibitors, are one way to treat gBRCA-mutated, HER2- LA/MBC.

TALZENNA is a potent PARP inhibitor that may help shrink or slow the growth of gBRCA-mutated, HER2- LA/MBC. TALZENNA may also cause serious side effects. Please see Important Safety Information to learn more.

Use the yellow arrows to navigate the animation below, demonstrating how TALZENNA works to inhibit PARP.

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NORMAL CELL DNA

DNA is like a library full of instructions that tell the cell how to grow.

gBRCA=germline (or inherited) BRCA, HER2-=human epidermal growth factor receptor 2 (HER2)-negative, HR+=hormone receptor-positive, LA/MBC=locally advanced or metastatic breast cancer, PARP=poly (ADP-ribose) polymerase, TNBC=triple-negative breast cancer.

Important Safety Information and Indication

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Important Safety Information

TALZENNA may cause serious side effects, including:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with TALZENNA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with TALZENNA.

Symptoms of low blood cell counts are common during treatment with TALZENNA, but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with TALZENNA:

  • weakness
  • weight loss
  • fever
  • frequent infections
  • blood in urine or stool
  • shortness of breath
  • feeling very tired
  • bruising or bleeding more easily

Your healthcare provider will do blood tests to check your blood cell counts:

  • every month during treatment with TALZENNA
  • weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with TALZENNA until your blood cell counts improve.

Before taking TALZENNA, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems
  • are pregnant or plan to become pregnant. TALZENNA can harm your unborn baby, and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with TALZENNA. Tell your healthcare provider right away if you are pregnant or become pregnant during treatment with TALZENNA.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with TALZENNA and for at least 7 months after receiving the last dose of TALZENNA. Talk to your healthcare provider about forms of birth control that may be right for you.
    • Males with female partners who are pregnant or are able to become pregnant should use effective birth control during treatment with TALZENNA and for at least 4 months after receiving the last dose of TALZENNA.
  • are breastfeeding or plan to breastfeed. It is not known if TALZENNA passes into your breast milk. Do not breastfeed during treatment with TALZENNA and for at least 1 month after receiving the last dose of TALZENNA. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Taking TALZENNA and certain other medicines can affect how TALZENNA works and may cause side effects.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How to take TALZENNA

  • Take TALZENNA exactly as your healthcare provider tells you.
  • 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.

The most common side effects of TALZENNA when taken alone include:

  • low red blood cell counts
  • low white blood cell counts
  • low platelet counts
  • tiredness or weakness
  • increased blood glucose levels
  • increased liver function tests
  • low calcium in the blood
  • nausea
  • headache
  • vomiting
  • hair loss
  • diarrhea
  • decreased appetite

TALZENNA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of TALZENNA.

Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication

TALZENNA is a prescription medicine used:

  • alone to treat adults with a certain type of breast cancer (human epidermal growth factor receptor 2 [HER2]-negative)
    • who have an abnormal inherited BRCA gene, and
    • whose cancer has spread to other parts of the body (locally advanced or metastatic).

Your healthcare provider will perform a test to make sure that TALZENNA is right for you. It is not known if TALZENNA is safe and effective in children.

Please see Full Prescribing Information and Patient Information.