TALZENNA (talazoparib) is an oral inhibitor of poly ADP-ribose polymerase (PARP), which plays a role in DNA damage repair. Preclinical studies have demonstrated that TALZENNA blocks PARP enzyme activity and traps PARP at the site of DNA damage, leading to decreased cancer cell growth and cancer cell death.
TALZENNA is approved in over 70 countries, including the U.S., as a once-daily monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. In the U.S., TALZENNA is now approved in combination with XTANDI® (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Breast cancer is a malignant tumor that originates in the cells of the breast, commonly affecting the ducts and lobules. It is the most common cancer among women worldwide, though it can also occur in men. The development of breast cancer involves the abnormal growth of breast cells that can invade surrounding tissues and spread to other parts of the body (metastasize). Risk factors include genetic mutations (such as BRCA1 and BRCA2), family history of breast cancer, hormonal influences, and certain lifestyle factors such as alcohol consumption and obesity.
Early detection through screening methods like mammography, breast self-examinations, and clinical breast exams is crucial for effective treatment and improved survival rates. Treatment options vary based on the stage and subtype of breast cancer and may include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Advancements in personalized medicine and ongoing research continue to enhance the understanding and management of breast cancer, leading to more tailored and effective treatment approaches.
Companion diagnostic testing plays a critical role in the decision to treat breast cancer with Talzenna (talazoparib). Specifically, this testing is used to identify patients with germline BRCA1 or BRCA2 gene mutations, which are key indicators for the effective use of Talzenna. These mutations are associated with DNA repair defects that make cancer cells more susceptible to PARP inhibitors like Talzenna, which work by preventing cancer cells from repairing their DNA, leading to cell death.
For Talzenna, the FDA-approved companion diagnostic test is the BRACAnalysis CDx test by Myriad Genetics. This test determines the presence of deleterious or suspected deleterious germline BRCA mutations in patients diagnosed with HER2-negative breast cancer who are candidates for chemotherapy. The identification of these mutations through diagnostic testing is crucial as it ensures that Talzenna is specifically targeted to the patient subset most likely to benefit from its mechanism of action, thereby personalizing and optimizing breast cancer treatment.
To place your paper-based order, complete the Myriad Genetics paper test request form for BRACAnalysis CDx®, and fax it to 310-876-3216, or insert the form in the Myriad Genetics specimen collection kit before shipment.
TALZENNA (talazoparib) is a PARP inhibitor used to treat adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. TALZENNA works by interfering with the PARP enzymes that cancer cells need to repair their DNA, causing the cancer cells to die, particularly in tumors that already have impaired DNA repair mechanisms due to the BRCA mutation.
TALZENNA is recommended for patients with HER2-negative breast cancer who have a germline BRCA mutation. These mutations should be confirmed by an FDA-approved companion diagnostic test before starting treatment.
Common side effects of TALZENNA include fatigue, anemia, nausea, neutropenia (low levels of white blood cells), headache, vomiting, hair loss, diarrhea, and decreased appetite. It’s important for patients to manage these side effects in consultation with their healthcare provider.
TALZENNA is taken orally, once daily, with the dose adjusted based on individual tolerance and response to the medication. It should be taken approximately at the same time each day, with or without food.
Before starting treatment with TALZENNA, patients must undergo companion diagnostic testing to confirm the presence of BRCA mutations in their germline DNA. This ensures that TALZENNA is used in individuals most likely to benefit from treatment with a PARP inhibitor, enhancing both efficacy and safety.
Patients should discuss their complete medical history, especially any issues related to blood cell counts or kidney function. It’s also crucial to discuss all medications being taken, including over-the-counter drugs and supplements, to avoid potential interactions. Women of reproductive potential should discuss pregnancy plans and use effective contraception, as TALZENNA can harm a developing fetus.
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients with cancer. Our robust pipeline is focused on exploring the potential of innovative therapies to address significant unmet medical needs and to improve outcomes for cancer patients worldwide. With a portfolio of more than 20 approved cancer medicines and biosimilars, and a deep pipeline of investigational drugs, we aim to transform the cancer treatment landscape and redefine life with cancer. For more information, visit Pfizer.
