Advisory Panel Recommends Approval Of Pertuzumab For Use Before Surgery In Early Breast Cancer. The New York Times (9/13, Pollack, Subscription Publication) reports that a Federal advisory committee to the Food and Drug Administration voted 13 to 0, with one abstention, to recommend pertuzumab (Perjeta) for approval to treat breast cancer patients prior to surgery. Genentech’s Perjeta is already approved for the treatment of late-stage breast cancer, but “could also be used in some cases at the disease’s earliest stage, before women have surgery.” The Wall Street Journal (9/13, Dooren, Subscription Publication) reports that the drug would be used along with chemotherapy and trastuzumab (Herceptin). There was a concern among some panel members that the drug could be overused. Bloomberg News (9/13, Edney) adds that the recommendation puts the drug on track to “become the first pre-surgical drug treatment for breast cancer that could lead to a less-invasive procedure.” The advisory committee voted the benefits of the expanded use of the drug among breast cancer patients outweighed the potential risks. At the meeting, Richard Pazdur, director of the Office of Hematology & Oncology Products in the FDA’s Center for Drug Evaluation and Research, said it was a “significant quantum leap.” According to the AP (9/13, Perrone), “the FDA is considering granting Perjeta accelerated approval,” but the panel members emphasized that “Genentech must conduct more trials to prove that Perjeta’s early promise ultimately results in longer life expectancy for patients.” The AP notes that the Genentech study found some evidence of potentially serious side effects, such as increased rates of heart problems. Dr. Pazdur said, “The other side of the equation is you have to look at the benefit, and that is the introduction of an agent that may help many women prevent metastatic disease.” Also reporting on the story are Reuters (9/13, Clarke), the San Francisco Business Times (9/13, Leuty, Subscription Publication) “Biotech” blog, HealthDay (9/13, Steele), MedPage Today (9/13, Pittman), and Medscape (9/13, Mulcahy).
Posted on: Thu, 19 Sep 2013 19:39:18 +0000
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