Roche plans for global Pertuzumab approval

Roche plans to seek approval from the EMA and FDA for Pertuzumab, a medicine that could contribute to future HER2-positive cancer treatments.

In a recent trial, Roche claims that Pertuzumab proved successful at extending the time people lived with HER2-positive metastatic breast cancer (mBC) without their condition worsening.

The encouraging results were gathered in Roche’s Phase III study, CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab), and will be submitted at an upcoming meeting for regulatory approval of the medicine in Europe and the US.

CLEOPATRA is a randomised, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of Pertuzumab combined with Herceptin and docetaxel chemotherapy compared to Herceptin and docetaxel in people with HER2-positive mBC.

No new safety issues were discovered by the independent review.

“These results with Pertuzumab combined with Herceptin and docetaxel are very encouraging and represent our commitment to developing potential new personalised options for people with this aggressive disease,” said Hal Barron, M.D., chief medical officer and head, Global Product Development.

Pertuzumab is the first investigational medicine developed to specifically prevent the HER2 receptor from pairing with other HER receptors (EGFR/HER1, HER3 and HER4). This is thought to block cell signalling, which may inhibit cancer cell growth or lead to the death of the cancer cell. The mechanisms of action of Pertuzumab and Herceptin are believed to complement each other as both bind to the HER2 receptor but on different regions.

808 people from all over the world, with previously untreated HER2-positive mBC, tested the treatment over the course of three weeks.

Each year approximately 1.4 million new cases of breast cancer are diagnosed worldwide, and over 450,000 women will die of the disease annually. In HER2-positive breast cancer, increased quantities of the human epidermal growth factor receptor 2 (HER2) are present on the surface of the tumour cells. This is known as “HER2 positivity” and affects approximately 15-25 percent of women with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer and remains an incurable disease.