NICE recommends innovative breast cancer drug

The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Pfizer’s TALZENNA ^® (talazoparib) for HER2- negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations.

An important advance in treating breast cancer

The pharmaceutical company shared that its oral small molecule poly (ADP-ribose) polymerase (PARP) inhibitor is indicated in adults who have had an anthracycline or a taxane, or both, if suitable, and endocrine therapy in patients with hormone receptor (HR)-positive breast cancer, if suitable.

The mechanism of action for the treatment is that it reduces or slows the growth of certain types of cancer cells. During treatment, patients would be given talazoparib would be used instead of chemotherapy, according to a statement by NICE.

Positive recommendation of talazoparib “is an important advance in expanding treatment options for eligible patients who currently have limited alternative treatments,” Chris Twelves, Director of NIHR Leeds Clinical Research Facility and Professor of Clinical Cancer Pharmacology and Oncology noted.

Following NICE’s decision, Pfizer stated that the marketing authorisation was based on the “review of the results from an open-label, randomised parallel 2-arm multicentre study of talazoparib versus chemotherapy in patients with germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer, who received no more than three prior cytotoxic chemotherapy regimes for their metastatic or locally advanced disease.”

Weighing up the evidence

NICE emphasised that data from a clinical trial revealed that talazoparib increased patient survival without the disease worsening, compared with chemotherapy. Yet the trial “did not show any difference in how long people live.”  

The agency highlighted that in its earlier draft decision, it had previously recommended against its use in this indication as a treatment for the disease.

Now, NICE’s decision means that talazoparib “is the first BRCA-targeted treatment to be recommended in the advanced breast cancer setting in the NHS,” Stefano Podesta, Oncology Lead, Pfizer UK explained.

“Although some uncertainty in the clinical evidence remains, when considering the impact of advanced breast cancer and its effect on quality and length of life, the improved discount from [Pfizer] means we can now recommend talazoparib for use in the NHS,” explained NICE’s Director of Medicines Evaluation, Helen Knight.