HER2-positive breast cancer

September 13, 2019September 13, 2019

FDA to Review Nerlynx Combo as Third-line Treatment for HER2-positive Metastatic Breast Cancer

News

The U.S. Food and Drug Administration (FDA) has agreed to review Puma Biotechnology’s application seeking approval of Nerlynx (neratinib), in combination with capecitabine, to treat HER2-positive breast cancer patients with metastatic disease, the ... Read more

August 26, 2019September 18, 2019

Grant to Fund CAR T-cell Trial for HER2-Positive BC with Brain Metastases

News

The California Institute for Regenerative Medicine (CIRM) has granted a $9.28 million award to a group of City of Hope researchers carrying out a first-in-human Phase 1 clinical trial testing ... Read more

June 17, 2019

FDA Approves Herceptin Biosimilar Kanjinti for HER2-positive Breast Cancer

News

The U.S. Food and Drug Administration (FDA) has approved Amgen and Allergan’s Kanjinti (trastuzumab-anns), a biosimilar to Genentech’s Herceptin (trastuzumab), for all indications of its reference product — including as a treatment ... Read more

May 31, 2019May 31, 2019

Prestige’s HD201, a Biosimilar to Herceptin, Accepted for Review in Europe for HER2-positive BC

News

The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submitted by Prestige BioPharma for HD201, its lead biosimilar to Genentech‘s Herceptin (trastuzumab). Like Herceptin, HD201 ... Read more

May 22, 2019

Treatment Intensity Should Be Personalized in Women with HER2-positive Breast Cancer, Study Says

News

Personalized treatment intensity is crucial to the success of less toxic and demanding therapies for women with HER2-positive breast cancer, according to a spokesperson from the European Society for Medical ... Read more

May 15, 2019

Experimental Antibody Therapy Leads to Significant Responses in HER2-positive Breast Cancer, Phase 2 Trial Shows

News

Trastuzumab deruxtecan (DS-8201), an investigational antibody-drug conjugate developed by AstraZeneca with Daiicho Sankyo, led to clinically meaningful responses in patients with advanced HER2-positive breast cancer, a Phase 2 clinical trial ... Read more

April 12, 2019

Surgery Extends Lives of Women with Metastatic Breast Cancer, Study Says

News

Women with HER2-positive breast cancer that has spread to distant organs live longer if they have surgery to remove their primary tumor, according to research presented at the recent American ... Read more

March 11, 2019

NeuVax/Herceptin Combo Promotes Disease-free Survival in TNBC

News

Long-term treatment with a combination of NeuVax (nelipepimut-S) and Herceptin (trastuzumab) is safe and extends the time without disease resurgence in women with triple-negative breast cancer, according to final results of a Phase 2b ... Read more

December 17, 2018

Enrollment Complete in Phase 2 Trial of NeuVax-Herceptin for HER2-Positive, High-Risk Breast Cancer

News

The investigator-sponsored trial studying a combination of NeuVax (nelipepimut-S, NPS) and Herceptin (trastuzumab) as a maintenance treatment for HER2-positive breast cancer at high risk of recurrence has completed patient enrollment, Sellas Life Sciences, ... Read more

November 16, 2018

DoD Awards $11M for Phase 2 Trial of TPIV110 Breast Cancer Therapy

News

The U.S. Department of Defense (DoD) has awarded Mayo Clinic researchers $11 million to conduct a Phase 2 trial investigating the TPIV110 vaccine, in combination with Herceptin (trastuzumab), as a therapy ... Read more