Neratinib/T-DM1 Combo Shows Promise in HER2-Positive Breast Cancer

Excerpt:

“The combination of neratinib (Nerlynx) and T-DM1 (ado-trastuzumab emtansine; Kadcyla) induced an overall response rate of 60% in previously-treated women with HER2-positive metastatic breast cancer, according to results from the phase Ib NSABP FB-10 study presented at the 2018 ASCO Annual Meeting.

“Among 12 of 20 evaluable patients with objective responses, 3 had a complete response and 9 had a partial response. An additional 2 patients had stable disease, and 6 patients had progressive disease.”

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AACR 2018: Acquired HER2 Mutations Confer Resistance to Hormone Therapy in ER-Positive Metastatic Breast Cancer

Excerpt:

“Mutations in HER2 were found to confer resistance to hormone therapy in some estrogen receptor (ER)-positive metastatic breast cancer cases, and resistance could be reversed by dual treatment with the hormone therapy fulvestrant (Faslodex) and the HER2 kinase inhibitor neratinib (Nerlynx), according to data presented during a media preview for the 2018 American Association for Cancer Research (AACR) Annual Meeting, to be held April 14–18 in Chicago.”

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Targetable Mutations in NSCLC: More Testing Needed!


Diagnosis of adenocarcinoma of the lung, a major subtype of non-small lung cancer (NSCLC), nowadays triggers mandatory testing of tumor tissue for alterations in four genes: EGFR, ALK, ROS1, and more recently, BRAF. If present, these alterations predict sensitivity to specific targeted drugs approved by the U.S. Food and Drug Administration (FDA) that work better and often longer than standard chemotherapy, and are better tolerated.

However, there are many more targetable/actionable genomic alterations (also known as “drivers”) in NSCLC. This blog post will briefly discuss most of them, with the goal of promoting molecular testing for more than the four “usual suspects” mentioned above. Some patients with these alterations may benefit from FDA-approved drugs or from enrollment in clinical trials that are testing additional drugs and drug combinations. Continue reading…


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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