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Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval

Wednesday, June 21, 2023

Pfizer has announced that the U.S. Food and Drug Administration (FDA) has approved the use of TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). This approval is based on the positive results from the Phase 3 TALAPRO-2 trial, which showed a significant reduction in the risk of disease progression or death in patients with mCRPC with HRR gene mutations who were treated with TALZENNA plus XTANDI.

Metastatic castration-resistant prostate cancer (mCRPC) refers to prostate cancer that has spread beyond the prostate gland and has progressed despite treatment to lower testosterone levels. Approximately 10-20% of prostate cancer patients develop mCRPC within 5-7 years of diagnosis, and in 2020, it was estimated that 60-90 thousand cases of prostate cancer in the U.S. were mCRPC. HRR gene mutations are found in about 25% of tumors from men with mCRPC and are associated with aggressive disease and poor prognosis.

TALZENNA is an oral PARP inhibitor that blocks the activity of the PARP enzyme involved in DNA damage repair. It has previously been approved as a once-daily monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in over 70 countries, including the U.S.

XTANDI is an androgen receptor signaling inhibitor that has been approved as a standard of care for different stages of prostate cancer, including metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), and non-metastatic castration-resistant

prostate cancer (nmCRPC) in the United States and numerous other countries. It has been used by over one million patients worldwide.

The combination of TALZENNA and XTANDI has demonstrated significant improvements in delaying or preventing disease progression or death in patients with HRR gene-mutated metastatic castration-resistant prostate cancer. This approval provides a new treatment option for patients with this aggressive form of prostate cancer and represents an important advancement in managing the disease.Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval



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