Posts by: Alice Melão

News

The U.S. Food and Drug Administration (FDA) has approved Foundation Medicine’s FoundationOne CDx as a companion diagnostic test for identifying advanced breast cancer patients with a PIK3CA mutation suitable ... Read more

November 6, 2019

First Patient Dosed in Phase 3 Trial of Tucatinib-Kadcyla Combo for Advanced HER2-Positive Breast Cancer

News

A Phase 3 trial exploring a combination of Seattle Genetics‘ tucatinib plus standard Kadcyla (ado-trastuzumab emtansine) in people with advanced HER2-positive breast cancer has dosed its first participant, the ... Read more

October 28, 2019October 28, 2019

FDA Supports Use of Anti-diarrheal Medications with Nerlynx

News

The U.S. label of Nerlynx (neratinib), a treatment for early stage HER2-positive breast cancer, now includes information on the use of two anti-diarrheal medications to prevent severe side effects of the ... Read more

August 14, 2019

Eagle Prepares Clinical Trials of New Form of Fulvestrant to Treat ER-positive Breast Cancer

News

Eagle Pharmaceuticals is preparing a pilot study that may pave the way for a pivotal clinical trial evaluating its new formulation of fulvestrant as a treatment for estrogen receptor (ER)-positive ... Read more

August 5, 2019September 10, 2019

First Generic Version of Navelbine Launched in Europe for Breast, Lung Cancers

News

Lotus Pharmaceuticals has launched the first generic version of Pierre Fabre’s Navelbine (vinorelbine) in soft capsule form in Europe for the treatment of advanced breast cancer and advanced non-small-cell ... 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 ... 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