By: Chris Ryan From: onclive.com The FDA has approved vepdegestrant (Veppanu) for the treatment of adult patients with estrogen receptor (ER)–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least 1 line of endocrine therapy.1,2 The approval was backed by data from the phase 3 VERITAC-2 trial (NCT05654623), which demonstrated …
FDA Approves Imlunestrant for ER+, HER2-Negative, ESR1-Mutated Metastatic Breast Cancer
By: Ashling Wahner From: onclive.com The FDA has approved imlunestrant (Inluriyo) for the treatment of adult patients with estrogen receptor (ER)–positive, HER2-negative advanced or metastatic breast cancer harboring ESR1 mutations whose disease has progressed following 1 or more prior lines of endocrine therapy.1,2 The FDA has also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients …
FDA Approves Inavolisib Plus Palbociclib/Fulvestrant for Endocrine-Resistant, PIK3CA-Mutated, HR+, HER2– Advanced Breast Cancer
By: Chris Ryan From: onclive.com Key Takeaways Inavolisib, combined with palbociclib and fulvestrant, is approved for specific breast cancer patients with PIK3CA mutations. The INAVO120 trial showed a median progression-free survival of 15.0 months for the inavolisib group versus 7.3 months for the placebo group. The FDA has approved inavolisib (Itovebi) in combination with palbociclib (Ibrance) and fulvestrant (Faslodex) for …
FDA Approval Sought for Lumisight Optical Imaging Agent to Assist in Intraoperative Breast Cancer Detection
By: Kristi Rosa From: onclive.com A new drug application (NDA) seeking the approval of Lumisight, an optical imaging agent that detects cancerous tissue during initial lumpectomy to allow for a more complete resection, has been submitted to the FDA.1 The investigational proprietary onco-fluorescent agent should be used with the Lumicell Direct Visualization System (DVS) to find, view, and guide the …
FDA Expands Abemaciclib Indication in HR+, Node+, High-Risk Breast Cancer
By: Kristi Rosa From: onclive.com he FDA approved an expanded indication for abemaciclib (Verzenio) in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer that is at a high risk of recurrence. Now, those determined to be high risk who are eligible to receive the agent can be identified based …
Gilead Sciences Drug Wins FDA Approval in Most Common Type of Breast Cancer
By: Frank Vinluan From: medcitynews The FDA has expanded the approval of a Gilead Sciences drug, a decision that clears the way for the therapy to reach more patients and potentially achieve the blockbuster status the company hoped for when it acquired the therapy in a multi-billion dollar deal. The drug, Trodelvy, was initially approved for treating triple negative breast …
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
Source: fda.gov Today, the U.S. Food and Drug Administration approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (spread to other parts of the body) HER2-low breast cancer. This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of …
FDA expands Enhertu approval for breast cancer
From: healio.com The FDA expanded the approval of fam-trastuzumab deruxtecan to include treatment of patients with HER2-positive metastatic breast cancer who received a prior anti-HER2-based regimen. Fam-trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) is a novel antibody-drug conjugate with three components: a humanized anti-HER2 immunoglobulin G1 monoclonal antibody with the same amino acid sequence as trastuzumab (Herceptin, Genentech); a topoisomerase 1 …
BriaCell Receives FDA Fast Track Approval for Targeted Breast Cancer Immunotherapy
Source: BriaCell Therapeutics Corp. From:yahoo.com BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to BriaCell’s lead candidate, Bria-IMT™, for the treatment of metastatic breast cancer (breast cancer that has spread beyond the …
FDA approves Lynparza for new breast cancer indication
From: healio.com/news The FDA expanded the approval of olaparib to include a new breast cancer indication. The approval applies to use of the agent as adjuvant treatment for patients with germline BRCA-mutated, HER2-negative high-risk early breast cancer who received chemotherapy in the neoadjuvant or adjuvant settings. Olaparib (Lynparza; AstraZeneca, Merck) is a poly(ADP-ribose) polymerase (PARP) inhibitor approved in the United …