Perjeta recommended in EU
pharmafile | December 18, 2012 | News story | Sales and Marketing | CHMP, Cancer, Perjeta, Roche
Roche’s breast cancer treatment Perjeta has been given the thumbs up by the CHMP, paving the way for its approval across Europe.
The influential committee has given a positive opinion for Perjeta (pertuzumab) to be used with Roche’s own Herceptin (trastuzumab) and docetaxel chemotherapy.
Patients with HER2-positive metastatic or locally-recurrent unresectable breast cancer (mBC) would receive this combination, which data released earlier this month showed helps reduce the risk of death by 34% versus Herceptin and chemotherapy alone.
The CHMP based its decision on the Phase III CLEOPATRA study, which 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 CHMP positive opinion for Perjeta brings us a significant step closer to the approval of a new personalised medicine for people with this aggressive form of breast cancer,” said Hal Barron, Roche’s head of global product development.
The FDA approved Perjeta in this combination for previously untreated patients with HER2-positive mBC in June.
“Perjeta complements Herceptin in attacking HER2-positive tumours and we believe Perjeta will transform the way people with HER2-positive metastatic breast cancer are treated,” Barron added.
The two drugs target different places on the HER2 receptor, a protein found in high quantities on the outside of cancer cells in HER2-positive cancers.
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.
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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