Posts by: Alice Melão

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 ... Read more

March 20, 2019

CHMP Favors EU Approval of Lynparza for Some Advanced Breast Cancers

News

The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended the approval of Lynparza (olaparib) tablets for the treatment of advanced ... Read more

February 6, 2019

Knight Therapeutics Acquires Exclusive Marketing Rights to Nerlynx in Canada

News

Breast cancer treatment Nerlynx (neratinib) will be exclusively commercialized in Canada by Knight Therapeutics, under an agreement with the therapy’s developer, Puma Biotechnology. Nerlynx is currently being reviewed by Health Canada as ... Read more

January 25, 2019

FDA Wants More Data Before Sacituzumab Govitecan Is Approved for Metastatic Triple-negative Breast Cancer

News

The U.S. Food and Drug Administration (FDA) has rejected Immunomedics’ application for accelerated approval of sacituzumab govitecan as third-line treatment for advanced triple-negative breast cancer (TNBC), the company announced. ... Read more

January 21, 2019

Phase 3 Trial of Oraxol for Metastatic Breast Cancer Is Fully Enrolled

News

The Phase 3 trial assessing Athenex‘s Oraxol — an oral formulation of the chemotherapy paclitaxel — for the treatment of advanced breast cancer has completed its planned patient enrollment. The progression ... Read more

January 9, 2019

FDA OKs Phase 2 Trial of AE37-Keytruda Combo in Metastatic Triple-negative Breast Cancer

News

Generex Biotechnology is planning a Phase 2 trial to test a combination of its AE37 peptide vaccine and Keytruda (pembrolizumab) in patients with advanced triple-negative breast cancer, after the U.S. Food and Drug ... Read more

January 4, 2019

Phase 3 Trial of Sacituzumab Govitecan Recruiting Triple-negative Breast Cancer Patients

News

A Phase 3 trial is recruiting participants to examine the effects of sacituzumab govitecan in patients with metastatic triple-negative breast cancer (TNBC) who failed to respond, or relapsed after at least ... Read more

January 2, 2019

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 ... Read more

December 10, 2018

Phase 1/2 Trial Testing Combo of Bria-IMT and Immune Checkpoint Inhibitors Begins Dosing Breast Cancer Patients

News

BriaCell Therapeutics has started patient dosing in a Phase 1/2a clinical trial testing its immunotherapy candidate Bria-IMT — used in combination with the immune checkpoint inhibitors Keytruda (pembrolizumab) or Yervoy (ipilimumab) ... Read more

Posts by: Alice Melão

Alice Melão

FDA Approves Herceptin Biosimilar Kanjinti for HER2-positive Breast Cancer

CHMP Favors EU Approval of Lynparza for Some Advanced Breast Cancers

Knight Therapeutics Acquires Exclusive Marketing Rights to Nerlynx in Canada

FDA Wants More Data Before Sacituzumab Govitecan Is Approved for Metastatic Triple-negative Breast Cancer

Phase 3 Trial of Oraxol for Metastatic Breast Cancer Is Fully Enrolled

FDA OKs Phase 2 Trial of AE37-Keytruda Combo in Metastatic Triple-negative Breast Cancer

Phase 3 Trial of Sacituzumab Govitecan Recruiting Triple-negative Breast Cancer Patients

Top 10 Breast Cancer Articles of 2018

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

Phase 1/2 Trial Testing Combo of Bria-IMT and Immune Checkpoint Inhibitors Begins Dosing Breast Cancer Patients

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