Roche gearing up to seek approvals of breast cancer treatment

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Roche has its eyes on another cancer drug approval after the Swiss drug giant met the primary goal of a pivotal trial for a combination therapy against a form of breast cancer. Yet at least one analyst questions whether the data are enough for a U.S. market green light.

The trial found that the experimental antibody pertuzumab, when given with Herceptin and the chemo drug docetaxel, helped patients with HER2-positive breast cancer live longer without their cancer getting worse than those who got only Herceptin and chemo. With no new safety issues found in the study, Roche aims to seek regulatory approvals for the treatment this year.

"These results with pertuzumab combined with Herceptin and docetaxel are very encouraging and represent our commitment to developing potential new personalized options for people with this aggressive disease," Hal Barron, Roche's chief medical officer and global head of product development, said.

While the trial hit its primary endpoint of progression-free survival, Sanford C. Bernstein analyst Jack Scannell said Roche might need to come to regulators in the U.S. with data on overall patient survival to gain approval. "The Food and Drug Administration wonders if a therapy is worth approving if all it can claim is that it slows the rate at which CT and MRI scans get worse," Scannell wrote today in a note to clients, as cited by Bloomberg. "The size of pertuzumab's incremental benefit may also come under scrutiny given the likely cost."

Any way you look at the data, breast cancer remains a disease without a cure. With pertuzumab, Roche at least has a new way to home in on HER2, which is a driver of growth in about a quarter of all breast cancers. It's also the receptor that Roche's blockbuster drug Herceptin targets. Yet the experimental antibody hits a different region of the receptor, providing a multi-pronged attack on the breast tumors.

- here's Roche's release
- see the coverage from Bloomberg
- have a look at Reuters' report

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