Around 2,000 women in the UK with an aggressive form of breast cancer could now benefit from Roche’s Perjeta earlier in the treatment pathway after regulators expanded the drug’s license.

Perjeta is a first-in-class HER2 dimerisation inhibitor that works synergistically with Herceptin (trastuzumab) to block cancer cell survival and growth signals. 

The drug was initially licensed for previously-untreated advanced HER2-positive breast cancer, but can now also be used pre-surgery for locally advanced, inflammatory or early-stage disease at high risk of recurrence.  

Its expanded approval comes on the back of data from two key studies, including NEOSPHERE, which showed that the Perjeta regimen nearly doubled the number of women whose tumours were eradicated compared with current treatment, and that patients were 40% more likely to be disease-free after three years.

“There is a need to bring effective medicines to patients with cancer earlier. Perjeta has already shown the longest survival benefit in patients with previously untreated advanced HER2-positive breast cancer, so it is very encouraging to see its authorisation in an earlier setting in order to further improve the long-term outcomes for patients with this aggressive disease,” noted Andrew Wardley, consultant in Medical Oncology at The Christie NHS Foundation Trust who was also involved in trials of the drug.

Perjeta was deemed too expensive by the National Institute for Health and Care Excellence for routine NHS use, but is still available to patients with previously-untreated advanced disease through England’s Cancer Drugs Fund, although it isn’t currently listed on the CDF in the early indication.