FDA Approves New Treatment to Reduce the Risk of Breast Cancer Returning

Excerpt:

“The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.”

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FDA Panel Backs Novel Anti-HER2 Drug for Breast Cancer

Excerpt:

“Another potential drug for HER2-positive breast cancer received strong numeric support from an FDA advisory committee, tempered by reservations about a broad indication, modest clinical benefit, and toxicity issues.

“By a 12-4 vote, the Oncologic Drugs Advisory Committee (ODAC) supported FDA approval of the dual HER2/EGFR inhibitor neratinib for early HER2-positive breast cancer that relapses after trastuzumab (Herceptin) maintenance therapy.”

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FDA Accepts Neratinib NDA for HER2-Positive Breast Cancer

Excerpt:

“The FDA has accepted a new drug application (NDA) for neratinib as an extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin), according to a statement from the developer of the TKI, Puma Biotechnology.

“The application included findings from the phase III ExteNET study, in which neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, according to findings published in Lancet Oncology. The FDA completes a standard review within 12 months from the time of submission, which was completed for neratinib on July 21, 2016.”

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EMA Validation Puts Neratinib One Step Closer to Approval for HER2+ Breast Cancer

Excerpt:

“The developer of neratinib, Puma Biotechnology, has announced the European Medicines Agency (EMA) has validated the marketing authorization application for neratinib as a potential extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab (Herceptin).

“The validation confirms the completion of the submission process and starts the formal review by the Committee for Medicinal Products for Human Use (CHMP) and the subsequent final approval decision by the European Commission.

“The application was based on findings from the phase III ExteNET study, which were published in the Lancet Oncology. In this study, extended treatment with neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, representing a 33% improvement versus placebo (HR, 0.67; P = .009).”

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Innovative Trials Produce Promising Breast Cancer Drugs

Excerpt:

“An innovative set of clinical trials have identified two drugs that could provide a fighting chance for women with advanced breast cancer.

“The drugs, neratinib and veliparib, both appear effective in helping women diagnosed with stage 2 or 3 , researchers report.

“These are the first two drugs to come out of the I-SPY clinical , a research effort intended to streamline  testing by better guiding treatments to those who would most benefit from them, said one of the study authors, Dr. Laura Esserman. She is director of breast cancer care at the University of California, San Francisco’s Comprehensive Cancer Center.”

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

Excerpt:

“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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Neratinib Plus Paclitaxel vs. Trastuzumab Plus Paclitaxel in Breast Cancer

Excerpt:

“While neratinib plus paclitaxel was not superior to trastuzumab plus paclitaxel as first-line treatment for ERBB2-positive metastatic breast cancer in terms of progression-free survival, the combination was associated with delayed onset and reduced frequency of central nervous system metastases, a finding that requires a larger study to confirm, according to an article published online by JAMA Oncology.

“Metastatic ERBB2-positive breast cancer has a characteristic spread with most patients developing liver metastases and about half having poor prognosis with central nervous system involvement.

“Ahmad Awada, M.D., of the Jules Bordet Institute, Brussels, and coauthors conducted a randomized clinical trial to examine progression-free survival in women with recurrent or metastatic ERBB2-positive breast cancer. They also examined secondary outcomes that included time to symptomatic or progressive central nervous system lesions and safety.”

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Neratinib Improves DFS in HER2-Positive Breast Cancer

“Treatment with the tyrosine kinase inhibitor neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% in patients with early-stage HER2-positive breast cancer, representing a 33% improvement compared with placebo, according to findings from the phase III ExteNET study published in The Lancet Oncology.

“In the phase III study, which was also presented at the 2015 ASCO Annual Meeting, the 2-year DFS rate with placebo was 91.6% (HR, 0.67; 95% CI, 0.50-0.91; P = .009). In patients with both HER2- and HR-positive disease, the 2-year DFS rate was 95.4% with neratinib and 91.2% with placebo, representing a 49% benefit (HR, 0.51; P = .001).”


Case Study Shows Early Efficacy for Neratinib in HER2-Mutated Metastatic Breast Cancer

“Treatment with the second-generation HER2/EGFR-targeted TKI neratinib resulted in a partial response and dramatic improvement in functional status for a patient with HER2-mutated breast cancer, according to a single-patient case study published in the Journal of the National Comprehensive Cancer Network.

” ‘The treatment of this patient is an excellent example of collaboration between basic research, clinical application and biotechnology companies for the benefit of patients,’ co-author of the publication Noa Efrat Ben-Baruch, MD, head of the Department of Oncology, Kaplan Medical Center, Rehovot, Israel, said in a statement. ‘With the advent of molecular profiling of patients with metastatic disease, such collaborations are of utmost importance for the development of new drug candidates outside of formal clinical trials.’

“According to the authors of the study, these findings represent the first successful single-agent treatment for patients with breast cancer harboring an activating mutation in the HER2 tyrosine kinase. In most situations, HER2 tyrosine kinase mutations occur independently from HER2 gene amplifications, making these patients ineligible or unlikely to respond to traditional HER2-targeted therapies.”