HER2 Breast Cancer

Following initial breast cancer diagnosis by mammography, MRI, or ultrasound, treatment is largely based upon the histologic subtype and staging of the tumor(s).

The most common adverse reactions observed in the monarchE phase 3 trial include diarrhea, neutropenia, fatigue, infections, nausea, abdominal pain, vomiting, anemia, alopecia, decreased appetite, and leukopenia.

Trastuzumab deruxtecan (T-DXd) (Enhertu) demonstrated strong efficacy in a phase 2 trial for treatment of HER2-positive metastatic breast cancer.

The objective of the study was to develop an education program that increased confidence and knowledge of pharmacists managing CDK4/6 inhibitors.

This approval is a part of the first Project Orbis partnership between the FDA, Health Sciences Authority, and Swissmedic.

Trastuzumab-dttb was first approved in January 2019 across all eligible indications, mainly adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer.

Officials from the FDA have approved a supplemental New Drug Application (sNDA) for neratinib (NERLYNX, Puma Biotechnology) in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer that have received 2 or more prior anti-HER2-based regimens in the metastatic setting.

HER2 is a membrane-bound tyrosine kinase that when amplified contributes significantly to a tumor’s ability to proliferate and survive.

A combination therapy may counter the resistance to human epidermal growth factor receptor 2 inhibitor neratinib in patients with breast, ovarian, lung, or other cancers.

Margetuximab plus chemotherapy showed positive results in a second pre-specified interim overall survival analysis for the phase 3 SOPHIA study.

By entering clinical and disease characteristics into a learning algorithm, researchers were able to create an efficacy prediction for CDK inhibitors.

Abemaciclib is a potent oral cyclin-dependent kinase 4/6 inhibitor that has previously demonstrated statistically significant improvement in PFS and ORR in combination with endocrine therapy.

Officials with the FDA have granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi-Sankyo) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer that have received 2 or more prior anti-HER2-based regimens in the metastatic setting.

Cyclin-dependent kinase 4/6 inhibitors offer the potential to significantly improve outcomes for women with HR-positive, HER2-negative breast cancer.

The study results also show improved outcomes for patients with brain metastases.

Puma’s supplemental New Drug Application is seeking approval for the use neratinib (Nerlynx) plus capecitabine as a third-line treatment in patients with human epidermal growth receptor 2-positive metastatic breast cancer.

Oncologists suggest that substituting nab-paclitaxel instead of paclitaxel prior to surgery may lead to reduced risk of disease recurrence for certain women with breast cancer.

Abemaciclib (Verzenio, Eli Lilly) in combination with fulvestrant demonstrated a statistically significant improvement in overall survival among women with metastatic breast cancer previously treated with endocrine therapy.

New study demonstrates a novel approach of linking HER2-targeting antibodies with chemotherapy drugs for patients with breast cancer.

Certain HER2-positive breast cancers may benefit from anti-HER2 therapy alone without the need for chemotherapy.

Ado-trastuzumab emtansine (Kadcyla) is currently the only antibody-drug conjugate approved for the treatment of HER2-positive early and metastatic breast cancer.

Study finds that surgery was associated with a 44% increased chance of survival in patients with breast cancer, assuming the majority also had systemic treatment.

Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta, Genentech) is indicated for subcutaneous administration in certain patients with HER2-positive early and metastatic breast cancer.

Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta, Genentech) is indicated for subcutaneous administration in certain patients with HER2-positive early and metastatic breast cancer.

The trial evaluated margetuximab compared with trastuzumab, in combination with chemotherapy, for the treatment of HER 2-positive breast cancer.

The FDA has approved trastuzumab-pkrb (Herzuma, Celltrion) as a biosimilar to trastuzumab (Herceptin, Genentech) for the treatment of HER2-overexpressing breast cancer.

Officials with the FDA have approved talazoparib (Talzenna, Pfizer) for the treatment of HER2-negative locally advanced or metastatic breast cancer with germline BRCA (gBRCA) mutations.

Talazoparib, a poly ADP-ribose polymerase (PARP) inhibitor, is indicated for patients with known deleterious or suspected deleterious gBRCA-mutated breast cancer who are selected for the therapy based on an FDA-approved companion diagnostic.

Talazoparib is indicated for patients with known deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer.

Sequential administration of HER2+ therapy and chemotherapy did not affect survival outcomes in patients with breast cancer.