Genentech’s pertuzumab gets FDA approval

June 12, 2012 10:22 AM

Genentech, a member of the Roche Group, announced last Friday that the U.S. Food and Drug Administration (FDA) has approved Perjeta (pertuzumab).

PerjetaTM is approved in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. The approval is based on data from a Phase III study which showed that people with previously untreated HER2-positive mBC who received the combination of Perjeta, Herceptin and docetaxel chemotherapy lived a median of 6.1 months longer without their cancer getting worse (progression-free survival, or PFS) compared to Herceptin plus docetaxel chemotherapy (median PFS 18.5 vs. 12.4 months).

The combination of Perjeta, Herceptin and chemotherapy is the only regimen to have shown a significant improvement in PFS compared to Herceptin plus chemotherapy in people with previously untreated HER2-positive mBC.

Perjeta targets the HER2 receptor (like Herceptin), a protein found in high quantities on the outside of cells in HER2-positive cancers. Perjeta is believed to work in a way that is complementary to Herceptin, as the two medicines target different regions on the HER2 receptor.

With the approval, Genentech has agreed to post-marketing commitments related to the manufacturing process for Perjeta. These include FDA review of data from the next several productions of the medicine.

Perjeta will be available to people in the United States within two weeks. Roche has also submitted a Marketing Authorization Application to the European Medicines Agency for Perjeta in combination with Herceptin and docetaxel chemotherapy for the treatment of previously untreated HER2-positive mBC or locally recurrent, unresectable (inoperable) breast cancer, in people who have not received previous treatment or whose disease has returned after treatment in the early-stage setting. This application is currently under review by the EMA.

Editor’s note: This seems like a big step from Roche/Genentech against biosimilars but to get the reimbursement for such a combination will not be easy for the company. For more information about pertuzumab&trastuzumab, you can check our previous posts, some of which are listed below. 

Source: Genentech press release

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