Eisai Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency expects to complete priority review of the eribulin mesylate New Drug Application (NDA) for locally advanced or metastatic breast cancer on or before December 30, 2010, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date of September 30, 2010…

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the company’s trastuzumab-DM1 (T-DM1) Biologics License Application (BLA). As planned, Genentech will continue with its ongoing Phase III registrational T-DM1 trial, EMILIA. Genentech will continue to work with the FDA and expects to submit a new T-DM1 BLA in mid-2012…

A new test has been developed which can predict whether a breast cancer patient will respond to chemotherapy within 24-hours of starting treatment, thus sparing her unnecessary treatment and side effects, according to a study published in the medical journal Clinical Cancer Research. The test can also determine whether the woman can benefit from PARP-inhibitors, a promising new type of cancer treatment currently undergoing clinical trials. The test was developed at the Breakthrough Breast Cancer Research Centre, at The Institute of Cancer Research (ICR), London, England…

Preferred Imaging Centers has installed the Naviscan PEM scanner into its newest facility in Plano, TX, adding a dedicated breast imaging modality to its array of diagnostic tools. PEM (Positron Emission Mammography) scanners are high-resolution breast PET systems that show the location as well as the metabolic phase of a lesion. The metabolic view assists physicians in making the optimal patient care decision by providing an unprecedented ability to distinguish between benign and malignant lesions, what researchers term “specificity…

The Food and Drug Administration (FDA) has issued a Refuse to File letter for accelerated approval of Roche’s trastuzumab-DM1 (T-DM1) Biologics License Application, which was submitted in July 2010. Roche had requested accelerated approval for T-DM1 based on the results of a single-arm Phase II study. In that study one third of advanced HER2 positive breast cancer tumors shrank. The patients had received on average seven prior medications, including two HER2 targeted agents. HER2 is the abbreviation for “human epidermal growth factor receptor 2″…

Two articles published in the Aug. 24 issue of the journal Radiology suggest that doctors should more carefully consider the risks of radiation exposure when employing advanced diagnostic techniques to screen for breast cancer, the New York Times reports. To weigh the risks and benefits of an advanced imaging exam, doctors should consider the amount of radiation exposure from the test, the patient’s total past exposure and possible alternative screening techniques, according to the Times…

USA Today recently published an editorial and an opinion piece regarding the recent controversy surrounding the cancer drug Avastin. An FDA advisory panel in July voted 12-1 to recommend that the agency revoke Avastin’s approval to treat advanced breast cancer after two clinical trials showed it did not prolong life. FDA is expected to make its final decision by Sept. 17, USA Today reports. ~ USA Today: The debate over Avastin “is an instructive study in the balance the FDA has struck” on the issue of accelerated drug approvals, USA Today says in an editorial…

(MedPage Today) — Women who averaged one alcoholic drink a day had almost double the risk of hormone-sensitive breast cancer of nondrinkers, data from the Women’s Health Initiative (WHI) showed.

University of Alberta researcher Margie McNeely says results from an international study she was part of indicates certain precautions about the risk of lymphedema for breast cancer survivors are outdated. McNeely, from the Faculty of Rehabilitation Medicine, says women who’ve had breast cancer surgery are often warned that pressure changes in an airplane cabin could trigger lymphedema, chronic swelling in the arm. But the study she did with an Australian research team showed that only five per cent of these women are likely at risk of developing any arm swelling when flying…

Some advocacy groups and lawmakers are urging FDA not to revoke its approval of Roche’s Avastin for treatment of advanced breast cancer, arguing that such a decision would limit women’s access to the drug by prompting insurers to reject coverage for it, the Fiscal Times/Kaiser Health News reports. FDA is currently reviewing an advisory committee’s recommendation to revoke the drug’s approval for breast cancer treatment after a pair of recent studies showed the drug did not extend patients’ lives…