Perjeta approved in EU
pharmafile | March 7, 2013 | News story | Sales and Marketing | Perjeta, Roche
Roche’s oncology brand Perjeta has been approved in Europe to treat patients with an aggressive form of breast cancer.
The European Commission says Perjeta (pertuzumab) can be used with Roche’s own Herceptin (trastuzumab) and docetaxel chemotherapy in patients with previously untreated HER2-positive metastatic breast cancer (mBC).
Perjeta was recommended by the CHMP in December after data showed it helped reduce the risk of death by 34% versus Herceptin and chemotherapy alone.
The Phase III CLEOPATRA study also showed the combination extended progression-free survival by 6.1 months from 12.4 months (for those just on Herceptin and chemotherapy) to 18.5 months.
“The EU approval of Perjeta is the result of years of research into the HER2 pathway and we are excited to offer a new treatment option,” said Hal Barron, Roche’s chief medical officer and head, global product development.
“The combination of Perjeta, Herceptin and chemotherapy is the first to significantly extend survival compared to the previous standard of care, Herceptin and chemotherapy alone,” he added.
There is another reason why Roche is so pleased with this decision: Herceptin will start to lose patent protection soon and Perjeta is expected to make up some of the shortfall, with a predicted $1.8 billion in peak annual sales.
Perjeta and Herceptin are believed to be complementary because they target different places on the HER2 receptor, a protein found in high quantities on the outside of cancer cells in HER2-positive cancers.
A diagnostic HER2 test is used to determine if a patient has HER2-positive breast cancer.
The newer drug is designed to prevent the HER2 receptor from pairing with HER receptors EGFR/HER1, HER3 and HER4 on the surface of cells – a process that is thought to aid tumour growth and survival.
The drug’s binding to HER2 may also give a signal to the body’s immune system to destroy the cancer cells, Roche says.
The FDA approved Perjeta in this combination for previously untreated patients with HER2-positive mBC last June and Roche says it expects further approvals during 2013.
Breast cancer is the most common cancer among women, with 1.4 million new cases diagnosed worldwide each year and 450,000 deaths annually.
Adam Hill
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