Fam-Trastuzumab Deruxtecan-nxki Approved for Treatment of Breast Cancer

The FDA has approved fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo, Inc.) for treatment of patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)–positive breast cancer. The approval is specific to individuals who have had prior treatment with an anti–HER2-based regimen in the metastatic, neoadjuvant, or adjuvant setting and have developed disease recurrence within six months of completing therapy. "Although HER2-targeted therapies have improved dise...

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Advanced Gastric Cancer: [Fam-] Trastuzumab Deruxtecan Shows Promise

A phase 1 clinical trial reports that [fam-] trastuzumab deruxtecan shows preliminary activity in patients with heavily pretreated human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction cancer. "These results are encouraging given the limited options for patients with advanced HER2-positive gastric cancer that progresses after initial treatment regimens including trastuzumab," commented Kohei Shitara, MD, Chief of the Department of Experimental Therapeutic...

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[Fam-] Trastuzumab Deruxtecan in Advanced Gastric Cancer With Kohei Shitara, MD

Current treatment options are highly limited for patients with advanced human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction cancer, particularly after trastuzumab. A potential new treatment has emerged in a phase 1 clinical trial, which reports that [fam-] trastuzumab deruxtecan shows preliminary activity in patients with heavily pretreated HER2-positive gastric or gastro-esophageal junction cancer. In this interview with i3 Health, Kohei Shitara, MD, l...

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Tucatinib for HER2-Positive Metastatic Breast Cancer: Eric P. Winer, MD

In this interview with i3 Health, Eric P. Winer, MD, discusses tucatinib (TukysaTM, Seattle Genetics), recently approved by the FDA in combination with trastuzumab and capecitabine for patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer previously treated with at least one anti-HER2­–based regimen in the metastatic setting. Dr. Winer, principal investigator of the phase 3 HER2CLIMB trial, on which the approval was based, discusses tucat...

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Pyrotinib/Capecitabine Effective for HER2-Positive Metastatic Breast Cancer

Pyrotinib, an irreversible pan-ErbB inhibitor, provides an effective treatment option in combination with capecitabine for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer, according to results of a phase 3 trial to be presented later this month in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program. The open-label, multicenter PHOEBE trial enrolled patients with HER2-positive metastatic breast cancer following treatment...

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Tucatinib Approved: Metastatic HER2-Positive Breast Cancer

The FDA has now approved tucatinib (TukysaTM, Seattle Genetics) in combination with trastuzumab and capecitabine for adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer, previously treated with at least one anti-HER2-based regimen in the metastatic setting. The tucatinib indication includes patients with brain metastases. The approval for tucatinib, a highly selective inhibitor of the HER2 tyrosine kinase, is based on data from HER2CLIMB ...

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Neratinib: Progress for HER2-Positive Metastatic Breast Cancer With Adam Brufsky, MD, PhD, FACP

Last week, the FDA added a second approval for neratinib (Nerlynx​®​, Puma Biotechnology, Inc.) in combination with capecitabine for adults with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer previously treated with at least two anti-HER2–based regimens in the metastatic setting. This adds to the previous approval of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, for the extended adjuvant treatment of early-stage HER2-positive breast cancer followi...

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Neratinib Approved: HER2-Positive Metastatic Breast Cancer

The FDA has approved a supplemental New Drug Application (sNDA) for neratinib (Nerlynx®, Puma Biotechnology, Inc.) in combination with capecitabine for adults with human epidermal growth factor receptor 2 (HER2)-positive advanced or metastatic breast cancer previously treated with at least two anti-HER2–based regimens in the metastatic setting. Neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), has previously been approved for the extended adjuvant treatment of adults with early...

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Subcutaneous Trastuzumab Approved for HER2-Positive Breast Cancer

The FDA has approved subcutaneous trastuzumab/hyaluronidase-oysk injection (Herceptin HylectaTM, Genentech, Inc.) for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The approval of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, in combination was based on two phase 3 clinical trials, HannaH (NCT00950300) and SafeHer (NCT01566721). HannaH, an international, open-label study, compared the pharmacokinetics, efficacy, and...

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Subcutaneous Trastuzumab in HER2-Positive Breast Cancer: An Interview with Constance Visovsky, PhD, RN, ACNP, FAAN

​Recently, the FDA approved subcutaneous trastuzumab/hyaluronidase-oysk injection (Herceptin HylectaTM, Genentech, Inc.) for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. In this interview with i3 Health, Constance Visovsky, PhD, RN, ACNP, FAAN, Associate Professor at the University of South Florida's College of Nursing, discusses the significance of this approval and shares advice for nurses treating patients with breast cancer. Can you comment on the ...

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Ado-Trastuzumab Emtansine Approved in HER2-Positive Early Breast Cancer

The FDA has now approved ado-trastuzumab emtansine (Kadcyla®, Genentech Inc) for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer with residual invasive disease following neoadjuvant taxane and trastuzumab-based treatment. The clinical trial KATHERINE (NCT01772472), results of which were published in The New England Journal of Medicine, contained a population of 1,486 patients with HER2-positive early breast cancer. In order to qualify for the study, pat...

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Characterization of HER2-Positive Non-Invasive Breast Cancer

Ductal carcinoma in situ (DCIS), or non-invasive breast cancer, can mutate into metastatic breast cancer. Ductal carcinoma in situ is reported as being human epidermal growth factor receptor 2 (HER2) positive in 50% of cases; in contrast, invasive breast cancer (IBC) cases have a lower prevalence of HER2 positivity. In many cases, HER2-positive breast cancers have a tendency to be more aggressive than other types of breast cancer and can sometimes be difficult to treat, as these malignancies are...

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Trastuzumab Duocarmazine in HER2-Positive Cancers

​A phase 1 clinical trial reports that trastuzumab duocarmazine, a new antibody-drug conjugate that targets human epidermal growth factor receptor 2 (HER2), shows promise in patients with HER2-expressing breast cancer and in HER2-positive advanced and metastatic solid tumors. An antibody-drug conjugate is a type of immunotherapy containing a selective monoclonal antibody, a cytotoxic (cell-killing) agent that causes cell death in the target tumor cell, and a chemical linker that releases the cyt...

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