EMA’s CHMP backs Roche’s Perjeta combo in HER2-positive breast cancer

pharmafile | April 30, 2018 | News story | Sales and Marketing |  Cancer, Herceptin, Perjeta, Roche, breast cancer, pharma 

Roche’s Perjeta has edged one step closer to approval as a combo therapy after the EMA’s Committee for Medicinal Products for Human Use (CHMP) backed its use alongside Herceptin (trastuzumab) and chemotherapy in the adjuvant treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence.

The committee’s decision was made on the back of Phase 3 data derived from its use in over 4,800 HER2-positive EBC. These data demonstrated that Perjeta reduced the risk of invasive breast cancer recurrence or death by 19% compared to Herceptin and chemotherapy alone, and this risk reduction stood at 23% in lymph node-positive disease and 24% in hormone receptor-negative disease. The study found the drug’s safety profile to be consistent with previous data.

While the European Commission is not obligated to heed the committee’s advice, it is strongly expected to make a positive decision in the near future.

Around 100,000 European citizens are diagnosed with HER2-positive EBC every year, and the Perjeta-based regimen has already secured approval in the region for pre-surgery use. It has also been approved by the FDA since December in the post-surgery treatment of HER2-positive EBC at high risk of recurrence.

“The goal of treating early breast cancer is to provide the best chance for a cure. This is why we believe that building on the existing therapies is so vital,” commented Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s announcement brings hope that patients in Europe with HER2-positive early breast cancer, who are at a high risk of recurrence, will soon have a new treatment option to reduce the chance of their disease returning and potentially progressing to an incurable stage.”

Matt Fellows