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news.The US Food and Drug Administration (FDA) has approved Genentech's Perjeta (pertuzumab) for the treatment of HER2-positive metastatic breast cancer (mBC), in combination with Herceptin (trastuzumab) and docetaxel chemotherapy.
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The approval is based on a Phase III study in which combination of Perjeta, Herceptin and chemotherapy demonstrated a significant improvement in PFS compared to Herceptin plus chemotherapy in people with previously untreated HER2-positive mBC.
Perjeta is believed to work as a complementary to Herceptin, according to the company.
Perjeta is a drug that targets the HER2 receptor found outside of cells in HER2-positive cancers.
Global Product Development chief medical officer Hal Barron said the approval of Perjeta is an important advance in the treatment of HER2-positive metastatic breast cancer.
"Perjeta attacks HER2-positive tumors differently than Herceptin. Based on the way the two medicines work together, the combination plus chemotherapy can prolong the time before this aggressive cancer worsens compared to Herceptin and chemotherapy alone," Barron added.
With the approval, Genentech has agreed for post-marketing commitments of Perejeta manufacturing process.