The US Food and Drug Administration (FDA) has approved the use of talazoparib (Talzenna), to treat BRCA-mutated breast cancer.

Thursday 6 December 2018      Health information
a scientists with test tubes

Earlier this month, the US Food and Drug Administration (FDA) approved the use of a drug called talazoparib (Talzenna), to treat BRCA-mutated locally-advanced and secondary breast cancers. 

Talazoparib is the second of a new class of drugs, known as a PARP inhibitor, to be approved by the FDA to treat breast cancer in the United States. 

The news follows the results of a recent trial of 431 patients with locally advanced or secondary breast cancers where a mutation in either the BRCA1 or BRCA2 gene was present. The trial found that those receiving talazoparib on average gained an extra three months before their cancer got worse, compared to chemotherapy – the standard therapy for these patients.

Talazoparib was first studied as a cancer treatment by Breast Cancer Now-funded researchers in 2013 in a project led by Professor Alan Ashworth. 

Fiona Hazell, Director of Policy and Engagement at Breast Cancer Now, said:

The approval of talazoparib by the FDA provides another welcome step forward in treating BRCA-mutated secondary breast cancer in the United States – offering patients precious extra months before their disease progresses.

That we are now beginning to see new, targeted therapies like talazoparib benefitting patients is a testament to the years of hard work and dedication of our world-class researchers – and the generosity of our supporters.

With talazoparib having been submitted to the European Medicines Agency for licensing in this indication, we hope it can soon be quickly appraised by NICE, to ensure it can reach the NHS patients who desperately need it.

If we are to reach our ambition that by 2050, everyone who develops breast cancer will live, and live well, we need to ensure that that all patients across the UK have fair access to pioneering, clinically effective treatments – like PARP inhibitors – as soon as possible.

What is a PARP inhibitor?

PARP inhibitors are drugs which block a DNA repair molecule called PARP, preventing its normal function. 

They were first shown to target cancer vulnerabilities caused by faults in BRCA genes by researchers at the Breast Cancer Now Toby Robins Research Centre at The Institute of Cancer Research, London and their collaborators, back in 2005. 

PARP function is essential for the growth and survival of breast cancer cells if they don’t have fully functioning BRCA genes. Blocking PARP with talazoparib and other PARP inhibitors, disables the DNA repair process in breast cancer cells that have a mutation in their BRCA1 or BRCA2 genes, causing them to die. Read more about how PARP inhibitors work.

Use of PARP inhibitors in breast cancer

Olaparib was the first PARP inhibitor licensed by the FDA back in January 2018, and is used in the US to treat women and men with BRCA-mutated incurable breast cancer. A major clinical trial (OlympiAD) found that olaparib delayed the progression of the disease by an average of around three months compared to chemotherapy, for women with HER2-negative BRCA-mutated advanced breast cancer

Whilst talazoparib and olaparib can now be used in the United States, both drugs are still awaiting licensing by the European Medicines Agency.