Roche breast cancer drug granted priority review by FDA

As reported by the Wall Street Journal, the U.S Food and Drug Administration (FDA) has granted priority review to trastuzumab

emtansine, a breast cancer drug developed by Genetech and ImmunoGen and is in global development by Roche.

The drug works by using monoclonal antibodies to deliver cancer-killing agents specifically to tumor cells. It is proposed that the drug will be used to treat those patients who have an aggressive form of breast cancer whereby the tumor cannot be removed via surgery or metastasized.

The FDA grants priority to review medicines that are considered to offer significant therapeutic advancements over existing therapies. Daniel Junius, Chief Executive at ImmunoGen stated, “We’re very pleased that the FDA has granted priority review. This decision underscores the urgent need to have new and more effective treatment options available for patients with this cancer.”

But the good news does not stop there; Genetech has also announced that Roche’s marketing application to use the breast cancer drug to treat people aggressive breast cancer has also been accepted for review by the European Medicines Agency.

 

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