Pfizer’s Talzenna recommended by NICE for advanced breast cancer

Pfizer’s Talzenna (talazoparib) has become the first targeted treatment to be recommended by the National Institute for Health and Care Excellence (NICE) to treat HER2-negative locally advanced or metastatic breast cancer with BRCA1/2 mutations.

Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable.

Additionally, those with HR-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for this.

NICE’s final draft guidance, which reverses its earlier draft decision not to recommend Talzenna for this patient population, follows Pfizer’s offer of an increased discount of the treatment.

The agency estimates that 300 breast cancer patients, who would otherwise be limited to chemotherapy and best supportive care, will benefit from the new recommendation.

Stefano Podesta, oncology lead at Pfizer UK, said: “[The] decision is an important milestone for eligible patients with advanced-stage breast cancer with an inherited BRCA mutation to access this much-needed treatment.

“This is the first BRCA-targeted treatment to be recommended in the advanced breast cancer setting in the NHS.”

Helen Knight, director of medicines evaluation at NICE, said the announcement “addresses a significant need” by giving patients with these types of cancer access to an additional treatment.

She added that, because Talzenna is taken as a once-daily tablet, it is “much more convenient for people who would otherwise need to go into hospital for intravenous chemotherapy”.

NICE noted that clinical trial evidence showed that Talzenna increased how long patients lived without disease progression compared to chemotherapy, but did not show any difference in overall survival.

“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 the company means we can now recommend [Talzenna] for use in the NHS,” Knight said.

The recommendation comes less than two weeks after Talzenna was approved by the European Commission in combination with Pfizer’s Astellas-partnered androgen inhibitor Xtandi (enzalutamide) to treat adults with metastatic castration-resistant prostate cancer.