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 for ... Read more
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 company ... Read more
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 therapy. ... Read more
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 breast ... Read more
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 lung ... Read more
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
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 breast ... Read more
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 a ... Read more
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. The ... Read more
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 of ... Read more
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