Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Roche has received approval from the European Commission (EC) to use Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) and chemotherapy for the neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
Subscribe to our email newsletter
The approval is based on the benefit observed with the Perjeta regimen in achieving pathological complete response (pCR) in the neoadjuvant treatment of HER2-positive early breast cancer (eBC).
Neoadjuvant treatment is given before surgery and is aimed at reducing tumor size so it is easier to surgically remove, while pCR is achieved when there is no tumor tissue detectable at the time of surgery in the affected breast or in the affected breast and local lymph nodes.
Roche Global Product Development head and chief medical officer Dr Sandra Horning said: "Today’s approval is a significant milestone in the neoadjuvant treatment of HER2-positive early breast cancer, bringing Perjeta to patients years earlier than typical adjuvant treatment.
"We are committed to making the Perjeta regimen available to appropriate patients in the EU as early as possible."
Mainly, the approval is based on data from the neoadjuvant Phase II NeoSphere study, which showed that nearly 40% of people receiving the combination of Perjeta, Herceptin and chemotherapy achieved pCR in the affected breast and local lymph nodes compared to 21.5% of people who received Herceptin and taxane chemotherapy alone.
Data from the Phase II neoadjuvant TRYPHAENA study has also supported the EC approval.
In the TRYPHAENA study, pCR rates ranging from 54.7% to 63.6% were achieved across the three Perjeta-containing study arms.
Perjeta is already approved as neoadjuvant treatment for people with HER2-positive eBC in the US and 21 other countries.