• CHMP recommends EU approval of Roche’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence

    • May 1, 2018
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    Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast cancer (eBC) at high risk of recurrence. A final decision regarding the approval of the Perjeta-based regimen, along with the full details of the approved indication, is expected from the European Commission in the near future.

     “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,” said Sandra Horning, MD, 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.”

    The CHMP recommendation is based on results from a large phase III study (APHINITY) involving over 4,800 people with HER2-positive eBC.1 At the time of the primary analysis, with a median follow-up of 45.4 months, the Perjeta-based regimen significantly reduced the risk of invasive breast cancer recurrence or death by 19% compared to Herceptin and chemotherapy alone in the overall study population (HR=0.81, 95% CI 0.66-1.00, p=0.045).1

    The Perjeta-based regimen showed the greatest benefit in patients who are at high risk of recurrence:1

    • For patients with lymph node-positive disease, the risk of recurrence or death was reduced by 23% with the Perjeta-based regimen (HR=0.77; 95% CI 0.62-0.96, p=0.019).
    • Among patients with hormone receptor-negative disease, the Perjeta-based regimen reduced the risk of recurrence or death by 24% (HR=0.76; 95% CI 0.56-1.04, p=0.085).

    The safety profile of the Perjeta-based regimen was consistent with that seen in previous studies, with a low incidence of cardiac events and no new safety signals.

    Every year, almost 100,000 people in Europe are diagnosed with HER2-positive breast cancer, an aggressive type of the disease if left untreated. The majority of breast cancer cases are diagnosed at an early stage where the goal of treatment is to cure.  In the eBC setting, treatment may be given before surgery to shrink tumours and after surgery to help prevent the cancer from returning. Despite advances in the treatment of HER2-positive eBC, one in four people treated with Herceptin and chemotherapy will eventually see their cancer return in the long-term. There is currently no cure for breast cancer that recurs and reaches an advanced stage and treatment for advanced disease is given to prolong life for as long as possible.

    For people diagnosed with HER2-positive eBC, the Perjeta-based regimen has already been approved for use before surgery in the EU, the US and many other countries.11,12 In December 2017, the US Food and Drug Administration (FDA) also approved the Perjeta-based regimen as a post-surgery treatment of HER2-positive eBC at high risk of recurrence.11 Patients in the US with HER2-positive eBC, eligible for the Perjeta-based regimen, should therefore receive Perjeta and Herceptin for 18 cycles, irrespective of the time of surgery, to complete one year of treatment.

    The combination has also been previously approved for the treatment of people with advanced HER2-positive breast cancer, where it has been shown to significantly extend survival compared to Herceptin and chemotherapy alone.

    Perjeta works in combination with Herceptin to provide a more comprehensive, dual blockade of the HER2 receptor, thus preventing tumour cell growth and survival.

    For more information about HER2-positive breast cancer and the goals of treatment, visit our Breast Cancer Hub on roche.com.



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