FDA awards Roche priority review in HER2-positive breast cancer
pharmafile | October 2, 2017 | News story | Sales and Marketing | Cancer, FDA, Herceptin, Perjeta, Roche, breast cancer, pharma, pharmaceutical
Roche has revealed that its monoclonal antibody Perjeta (pertuzumab) has been awarded priority review by the FDA as an adjuvant treatment for HER2-positive early breast cancer in combination with Herceptin (trastuzumab) and chemotherapy.
The development means that the FDA has determined that Perjeta offers significant improvement over other treatments, and is expected to make a final approval decision by 28 January 2018. The regulator’s decision was based on Phase 3 trial results of the drug in 4,805 participants.
Perjeta functions by targeting the HER2 receptor, a protein prevalent on the outside of HER2-positive cancers, and preventing it from pairing with other HER receptors in a bid to neutralise growth and survival of the tumour. When used in combination with Herceptin, it is thought that this effect is bolstered via a dual blockade of HER signalling pathways to further inhibit growth and survival.
Perjeta is available in the US under accelerated approval for the neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer, as a combination therapy with Herceptin and docetaxel. It is approved in this combination against metastatic HER2-positive breast cancer.
“We are pleased to receive Priority Review for the Perjeta-based regimen for the adjuvant treatment of HER2-positive early breast cancer,” said Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “The goal of treating breast cancer early is to provide people with the best chance for a cure. Despite advances in the treatment of this disease, many people treated with the current standard of care still see their cancer return.”
Matt Fellows
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