By: Kristi Rosa From: onclive.com The FDA has approved a new drug application for Tepylute, a ready-to-dilute formulation to treat breast and ovarian cancers. The FDA has approved a new drug application (NDA) for Tepylute (formerly SH-105), a ready-to-dilute formulation to treat adenocarcinoma of the breast and ovary.1,2 Tepylute is a liquid form of the standard-of-care agent, thiotepa. The new …
Health Canada Approves Goserelin Acetate for High-Risk, ER+ Early and Advanced Breast Cancer
By: Caroline Seymour From: onclive.com Health Canada has approved a supplemental new drug application for goserelin acetate (Zoladex) 10.8 mg every 12 weeks in the management of women with estrogen receptor–positive early breast cancer with a high risk of recurrence or advanced breast cancer in the pre- and perimenopausal setting.1 The approval was based on several global trials that evaluated …
NICE approves routine use of drug combination for advanced breast cancer
From: nice.org Another life-extending drug combination for some people with advanced breast cancer will now be available for routine use in the NHS following its approval by NICE in final draft guidance published today (23 September 2022). Palbociclib (also called Ibrance and made by Pfizer) given with fulvestrant, another type of anti-cancer treatment, is recommended for adults with a type …
European Commission Approves Keytruda in Early-Stage Triple-Negative Breast Cancer
By: Staff Reporter From: precisiononcologynews.com Merck said Tuesday that the European Commission approved its anti-PD-1 therapy Keytruda (pembrolizumab) as a treatment for earlier stages of triple-negative breast cancer. Keytruda is already available in Europe for locally recurrent, unresectable or metastatic TNBC. The new approval will allow TNBC patients with locally advanced or early-stage disease to use Keytruda and chemo before …
Knight Therapeutics Announces Health Canada Approval for NERLYNX® (Neratinib) to Treat HER2-Positive Metastatic Breast Cancer
Source: Knight Therapeutics From: finance.yahoo.com Knight Therapeutics Inc. (TSX: GUD), (“Knight”) a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved NERLYNX® (neratinib) in combination with capecitabine for the treatment of adult patients with metastatic HER2-overexpressed/amplified breast cancer, who have received two or more prior anti-HER2-based regimens in the metastatic setting. The approval was based on results …
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