Puma Biotechnology Submits Marketing Authorization Application for PB272 (Neratinib) as Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer in Europe


“Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that it has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for neratinib. The potential indication is for the extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with trastuzumab (Herceptin®)-based adjuvant therapy. The submission is based upon the ExteNET Phase III study, which reached its primary endpoint whereby neratinib demonstrated a statistically significant reduction of risk of invasive disease recurrence or death versus placebo.”

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Extending Estrogen Suppressor May Aid Breast Cancer Patients, Study Says


“Women with early-stage breast cancer could benefit from taking an estrogen-suppressing drug for 10 years rather than the standard five, researchers reported here on Sunday, citing the results of a new study.

“In the study, postmenopausal women who took a drug known as an aromatase inhibitor for an additional five years lowered the risk of their cancer returning or of a new case of cancer occurring in the other breast.

“ ‘These data are important to millions of women around the world,’ Dr. Harold J. Burstein, a breast cancer expert and spokesman for the American Society of Clinical Oncology, said in a statement on Sunday. The results ‘suggest that longer durations of widely available therapy reduce the risk of cancer recurrence and prevent second cancers from arising.’

“The study is being presented Sunday at the oncology society’s annual meeting here and is being published by The New England Journal of Medicine.”

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Full Dose Radiotherapy to Whole Breast May Not Be Needed in Early Breast Cancer

“Radiotherapy to the whole breast is standard treatment after breast-conserving surgery for women with early breast cancer, even those who have a low risk of the disease returning in the breast (local relapse). However, whole breast radiotherapy can cause changes in the appearance of the breast, which may also be firmer and tender to the touch, resulting in psychological distress.

” ‘So we considered it important to set up a trial to answer the question: is full dose radiotherapy to whole breast needed in patients with low risk early breast cancer?’ Dr Charlotte Coles, MD, Consultant Clinical Oncologist at Cambridge University Hospitals NHS Trust, Cambridge, UK, told the 10th European Breast Cancer Conference (EBCC-10) today (Wednesday). One group of women received standard full dose radiotherapy to the whole breast. A second group received standard full dose to breast tissue closest to where the lump appears and a slightly lower dose further away. A third group received standard full dose radiotherapy to breast tissue closest to where the lump appears but no radiotherapy dose apart from this.”

Skipping ALND in Some Early Breast Cancers Is Criticized

“The American Society of Clinical Oncology’s (ASCO’s) new recommendation that that some women with early-stage breast cancer and minimal lymph node involvement can forgo extensive lymph node surgery has been questioned separately by two sets of clinicians.

“The guidelines were originally published in May 1 in the Journal of Clinical Oncology (JCO), the flagship journal of ASCO.

“Now, in letters to the journal published on September 22, critics are saying that there is not enough evidence to support the recommendation.

“But the investigators of the trial on which the recommendation is based argue back, saying it is time to skip the surgery in certain patients.”

Targets for Immunotherapy in Early-Stage Breast Cancer

The gist: Treatments called immunotherapies, which boost a patient’s own immune system to fight cancer, are an exciting area of cancer research. One kind of immunotherapy drug works by targeting a specific protein called PD-L1, which can help tumors evade immune system attack. Oncologists can figure out whether an anti-PD-L1 immunotherapy drug might work for a patient based on the amount of PD-L1 protein found in a tumor, but PD-L1 levels can be difficult to accurately detect. Researchers have now developed a new, better test to measure PD-L1 levels in early-stage breast cancer tumors. Anti-PD-L1 drugs are currently being tested in clinical trials with volunteer advanced breast cancer patients, and anti-PD-L1 drugs may soon also be tried in early-stage breast cancer patients.

“Yale Cancer Center researchers used a new molecular analysis tool to accurately detect the level of an important target for immunotherapy in early-stage breast cancers. The diagnostic test, using RNAScope, measures the amount of PD-L1 (programmed death ligand 1) mRNA in routine formalin-fixed cancer tissues and is devoid of many of the technical issues that plague antibody-based detection methods that have yielded conflicting results in the past. PD-L1 is the target of several novel immune stimulatory therapies in clinical trials. The findings were published in the Journal of Clinical Cancer Research in May.

“PD-L1 is a protein that plays an important role in suppressing immune response, and in cancer, it may allow tumors to evade immune attack. The study demonstrated that about 60 percent of early-stage breast cancers have PD-L1 expression, and a subset of these cancers also have large numbers of tumor infiltrating lymphocytes. High levels of lymphocytes and PD-L1 predicted for better survival, suggesting a beneficial role for the immune system in at least partially controlling these cancers.

” ‘This is exciting because these findings provide the rationale to test PD-L1 targeted therapies in breast cancer with the hope of further improving cure rates in early stage breast cancer,’ said Lajos Pusztai, MD, DPhil, professor of Medical Oncology and chief of Breast Medical Oncology at Smilow Cancer Hospital, Yale Cancer Center, and an author on the study. ‘Patients with many tumor infiltrating lymphocytes and high PD-L1 expression may be the ideal candidates for these therapies.’ “