NICE approves Roche’s Perjeta for breast cancer

pharmafile | November 16, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing |  NICE, Perjeta, Roche, breast cancer 

NICE has announced its approval of Roche’s Perjeta (pertuzumab) as a neoadjuvant treatment of HER2-positive, locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence, when used in combination with trastuzumab. It is estimated that around 1,380 women suffer from the illness annually.

Perjeta is a HER2 dimerisation inhibitor which works with Herceptin to block cancer cell survival and growth signals by targeting the HER2 receptor V a protein found on the surface of cells in HER2-positive breast cancers. Roche reported that the decision to approve the drug was influenced by its ability to meet the institute’s cost-effectiveness criteria; the drug was knocked back in May earlier this year as NICE “needed to have more evidence of its long-term clinical benefits, particularly its impact on overall survival.” 

Richard Erwin, general manager at Roche UK, released a statement on the news:

“This decision is a clear demonstration that when we work together we can get the right decision for patients.  This was not simply about price – the medicine in this setting met the cost effectiveness threshold. This was about NICE accepting that one of the clinical trial endpoints; pathological complete response (pCR), was more likely than not to have an association with longer term survival.

“NICE heard from a patient whose response to treatment with Perjeta was described by her clinician as spectacular,” he continued. “This positive decision is particularly welcome as, until recently, no new medicines for breast cancer patients had been approved in the last nine years. Over the last month, however, we have seen some positive progress with three breast cancer medicines approved in three weeks.

“It is critical that this momentum continues so that all patients can access new, innovative treatments in development.”

Matt Fellows