FDA Issues Positive Review - Medication Pertuzumab

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FDA Issues Positive Review Of Breast Cancer Medication Pertuzumab.

The Wall Street Journal (9/11, Dooren, Subscription Publication) reports that the Food and Drug Administration has issued a positive review on the early use of breast cancer drug pertuzumab (Perjeta), manufactured by Roche Holding AG, after it was shown to shrink tumors in some women prior to surgery. The drug is currently approved for women whose breast cancer has tested positive for the HER2 protein and spread beyond the breast. Roche’s Genentech unit developed the drug, which it now hopes to gain approval to use the drug shortly after diagnosis and before the cancer has spread. The FDA Oncologic Drugs Advisory Committee will consider the proposal on Thursday.

        Bloomberg News (9/11, Edney) reports that the FDA review noted “‘statistically significant improvements’ in eradication of tumor tissue were seen in patients receiving Perjeta compared to those on Roche’s Herceptin [trastuzumab].” FDA staff said additional research should be conducted by Roche “on the effect of antibiotics used to destroy cancer cells on patients’ heart safety,” and how patients respond to the drug “regimen depending on when the drugs are given.” Roche is seeking “expanded use of Perjeta under accelerated approval.”

        The AP (9/11, Perrone) adds that “Perjeta would be the first cancer drug approved for use as a pre-surgical step” if it gains approval, noting that it is still experimental to use cancer drugs prior to surgery. Doctors hope that pre-surgical treatment “could help shrink tumors to make them easier to remove,” and could even eliminate the need to surgically remove women’s breasts. In its review the FDA states, “Despite advances in systemic therapy of breast cancer, there remains a need to expedite drug development and approval of highly effective therapies for patients with high-risk early-stage breast cancer.” Also reporting on the story are Reuters (9/11), the San Francisco Business Times (9/11, Leuty, Subscription Publication) “Biotech” blog, and HealthDay (9/11, Steele).

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http://www.freep.com/article/20130910/FEATURES08/309100089/FDA-Drug-works-in-early-stage-breast-cancer

FDA: Drug works in early-stage breast cancer