(Reuters) Feb 07 - U.S. health regulators granted a priority review for an experimental Roche breast cancer drug that in clinical trials added six months to progression-free survival.
The Food and Drug Administration will make its decision on whether to approve pertuzumab by June 8, for patients with advanced HER2-positive breast cancer who have not received prior treatment or who have suffered a relapse following surgery.
The agency grants priority review to medicines that are considered potentially significant therapeutic advancements over existing therapies.
In the phase III CLEOPATRA trial, patients who received pertuzumab in combination with Herceptin (trastuzumab) and docetaxel lived for an average of 18.5 months without disease progression, compared with 12.4 months for those who got only Herceptin and docetaxel.
The pertuzumab-treated patients also had a 38% reduction in the risk of disease progression or death (HR=0.62, p <0.0001).
Overall survival data from that trial is not expected to be available until 2013, but the FDA apparently found the available progression-free survival data compelling enough to makes its decision prior to that.
"We have been researching HER2-positive breast cancer for more than 30 years, and we hope an expedited review will help us quickly bring another personalized medicine to people battling this aggressive disease," Hal Barron, Roche's chief medical officer, said in a statement.
The statement went on to explain that the drug works by preventing the HER2 receptor from pairing (dimerizing) with other HER receptors (EGFR/HER1, HER3 and HER4), "a process that is believed to play a critical role in the growth and formation of several different cancer types."
Roche has already submitted a Marketing Authorization Application to the European Medicines Agency for pertuzumab for treating previously untreated HER2-positive metastatic breast cancer.
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