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Two are better than one

12.06.2012 - FDA approves Roche's antibody pertuzumab (Perjeta). Given together with trastuzumab (Herceptin) it will help breast cancer patients.

Basel/Glostrup/Bethesda – The US Food and Drug Administration (FDA) has approved Roche's drug Perjeta (pertuzumab) as combination therapy of people with metastatic HER2-positive breast cancer who have not received HER2 therapy or chemotherapy before. When administered together with Herceptin (trastuzumab) and in combination with standard docetaxel chemotherapy, Perjeta showed an increase in progression-free survival time of 6.1 months. Data stems from a Phase III study, the treatment of the control group was Herceptin and docetaxel chemotherapy alone.

Both the HER2 signaling inhibitor Herceptin and the HER2 dimerisation blocker Perjeta are humanised monoclonal antibodies. And both target the HER2 receptor, a protein found highly enriched on the outside of cells in a kind of breast cancer aptly named HER2-positive metastatic breast cancer. However, both drugs act in a complementary fashion, meaning that they target different parts of the HER2 receptor.  Currently, Genentech, the manufacturer of Perjeta, is not able to meet demand. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said why the approval was given in spite of the shortage: "There's a need for the treatment of metastatic breast cancer and we do not want to delay the drug's availability to patients pending resolution of the production issues relating to further supply." 

In March, Roche filed an EU market authorisation application for the subcutaneous administration of Herceptin which is less invasive and takes less time.

On 12 June, cancer diagnostics company Dako Denmark A/S announced that the FDA has granted market authroisation for its HercepTestand HER2 FISH pharmDxKit as companion diagnostics for pertuzumab.

RegulationUKEU

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FundingEU

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ResearchUKEU

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BusinessUKIreland

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ResearchEUSwitzerland

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MergerUK

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AcquisitionUKDenmarkSpainGermanyFrance

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FundingEU

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Stock marketNetherlandsUKBelgium

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M and AUKIreland

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No liability assumed, Date: 29.07.2014