“We are seeing a significant shift in the treatment paradigm for early stage breast cancer,” Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a news release. “By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.”
In May 2012, the FDA issued a draft guidance about the use of pathologic complete response as an endpoint to support accelerated approval of a drug for neoadjuvant treatment of high-risk, early stage breast cancer. Under the FDA's accelerated approval program, patients are provided access to promising drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted. Earlier in September, the FDA's Oncologic Drugs Advisory Committee voted in favor of accelerated approval for the drug in the neoadjuvant setting (OT, 10/10/13 issue).
“It's a chance to get this drug to people quicker,” ODAC Chair Mikkael Sekeres, MD, MS, Director of the Cleveland Clinic Taussig Cancer Institute's Leukemia Program and Chair of the Hematology/Oncology Pharmacy and Therapeutics Committee and OT's Clinical Advisory Editor for Hematology/Oncology, said at that time. He also noted about the decision: “All eyes will be on the confirmatory APHINITY trial.”
Perjeta's accelerated approval for neoadjuvant treatment is based on a study of 417 patients randomly assigned to receive one of four neoadjuvant treatment regimens: trastuzumab plus docetaxel, Perjeta plus trastuzumab and docetaxel, Perjeta plus trastuzumab, or Perjeta plus docetaxel. Approximately 39 percent of the patients in the study receiving Perjeta plus trastuzumab and docetaxel achieved a pathologic complete response, compared to approximately 21 percent who received trastuzumab plus docetaxel.
The confirmatory trial for Perjeta's accelerated approval is being conducted in patients with HER2-positive breast cancer who have had prior breast cancer surgery and are at high risk of having their cancer return. More than 4,800 participants are enrolled in the trial intended to provide further data on efficacy, safety, and long-term outcomes. Results are expected in 2016.
The drug's new use is intended for patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (tumors greater than 2 centimeters in diameter or with positive lymph nodes), and who are at high risk of cancer metastasis or are at high risk of dying from the disease. Perjeta is intended to be used in combination with trastuzumab and other chemotherapy prior to surgery and, depending upon the treatment regimen used, may be followed by chemotherapy after surgery. Following surgery, patients should continue to receive trastuzumab to complete one year of treatment.
The FDA reviewed Perjeta's use for neoadjuvant treatment under the agency's priority review program, which provides for an expedited review of drugs that may offer major advances in treatment.
The most common side effects reported in participants receiving Perjeta plus trastuzumab and docetaxel were hair loss, diarrhea, nausea, and a decrease in infection-fighting white blood cells. Other significant side effects included decreased cardiac function, infusion-related reactions, hypersensitivity reactions, and anaphylaxis.
The drug is marketed by Genentech.
FDA Grants 510(k) Clearance for Digital HER2 Status Test
In another action, the FDA granted 510(k) clearance to Her2/neu IHC Digital Manual Read (Philips), a digital system to assess HER2 status in breast cancer patients to help determine treatment options. The 510(k) allows for the device to be marketed in the U.S., and demonstrates the device is safe and effective.
The automated digital slide creation system allows pathologists to use digitally stored Her2/neu IHC images to help in the detection and semi-quantitative measurement of immunohistochemically stained breast cancer tissue on their computer monitor.
The system was commercially introduced in Europe and Asia Pacific in 2012.© 2013 by Lippincott Williams & Wilkins, Inc.
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