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Pfizer’s TALZENNA® for Breast Cancer Treatment Receives NICE Approval

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The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Pfizer’s TALZENNA® (talazoparib) for the treatment of advanced breast or metastatic breast cancer. This is a significant advancement in breast cancer treatment as it marks the first recommendation for a BRCA-targeted therapy by NICE.

TALZENNA® is a poly (ADP-ribose) polymerase (PARP) inhibitor, administered orally, that is indicated for the treatment of HER2-negative, locally advanced, or metastatic breast cancer in adults with germline BRCA1 or BRCA2 mutations. It is suitable for patients who have previously received anthracycline or taxane therapies, or both, and for those with hormone receptor (HR)-positive breast cancer who have also undergone endocrine therapy.

A Targeted Breakthrough in Advanced Breast Cancer Treatment Recommended by NICE

The mechanism of action of TALZENNA® involves slowing or reducing the growth of specific cancer cells. It offers an alternative to chemotherapy for eligible patients, providing a more targeted approach to treatment. This recommendation from NICE is seen as a significant advancement in expanding treatment options for eligible patients who have limited alternatives. Professor Chris Twelves, Director of NIHR Leeds Clinical Research Facility, emphasized the importance of this recommendation in providing additional choices for patients.

Pfizer’s marketing authorization for TALZENNA® was based on the review of results from a clinical trial comparing talazoparib to chemotherapy in patients with germline BRCA-mutated, HER2-negative, locally advanced, or metastatic breast cancer. The trial demonstrated that talazoparib improved progression-free survival compared to chemotherapy, although there was no significant difference in overall survival.

Breast Cancer

Improved Discount from Pfizer Spurs NICE’s Recommendation of TALZENNA® for Advanced Breast Cancer

NICE initially had reservations about recommending talazoparib; however, the improved discount offered by Pfizer played a crucial role in changing their decision. This recommendation makes TALZENNA® the first BRCA-targeted treatment to be endorsed for advanced breast cancer treatment in the NHS, offering new hope for patients.

While there may be some uncertainty in the clinical evidence, the potential benefits of TALZENNA® in terms of quality and length of life, especially for patients with limited treatment options, have led to its endorsement by NICE. This recommendation reflects the commitment to exploring innovative therapies to benefit patients in need and represents a significant step forward in the fight against advanced breast cancer.


Resource: European Pharmaceutical Review, January 19, 2024

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