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FDA Expands Enhertu Approval to HER2-Ultralow Breast Cancer

In In The News by Barbara Jacoby

By: Charles Bankheadmetastatic From: medpagetoday.com The FDA expanded the approval of trastuzumab deruxtecan (T-DXd, Enhertu) to include treatment of unresectable/metastatic hormone receptor (HR)-positive, HER2-low/ultralow breast cancer. Approval stipulates use in patients with disease that has progressed on or proven unresponsive to at least one prior endocrine therapy in the metastatic setting, according to a statementopens in a new tab or …

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FDA Grants Breakthrough Device Designation to DCISionRT for Breast Cancer With DCIS

In In The News by Barbara Jacoby

By: Ashling Wahner From: onclive.com The FDA has granted a breakthrough device designation to the DCISionRT test for patients with breast cancer with ductal carcinoma in situ (DCIS), according to an announcement from PreludeDX.1 DCISionRT assesses individual recurrence risk after breast-conserving surgery alone and with the addition of radiotherapy in women diagnosed with breast cancer with DCIS—also described as stage …

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FDA Fast Tracks Emiltatug Ledadotin in Advanced/Metastatic Breast Cancer

In In The News by Barbara Jacoby

By: Jordyn Sava From: targetedonc.com The FDA has granted a new fast track designation to emiltatug ledadotin for the treatment of advanced or metastatic breast cancer, specifically targeting patients with HER2-low or HER2-negative disease, including TNBC.1 This designation applies to patients who have previously received a topoisomerase-1 inhibitor antibody-drug conjugate (ADC). Additionally, hormone-receptor positive patients must have either received prior …

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IceCure’s cryoablation system for breast cancer treatment gains FDA panel support

In In The News by Barbara Jacoby

From: medicaldevice-network.com Based on the latest recommendation, the company anticipates receiving marketing authorisation for the system in the first quarter of 2025. IceCure Medical has received a favourable recommendation for its ‘ProSense’ Cryoablation System from the Medical Device Advisory Committee Panel of the US Food and Drug Administration (FDA). Leveraging liquid nitrogen to target benign and malignant lesions, the ProSense …

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Women Will Be Notified Of Breast Density After a Mammogram: What to Know

In In The News by Barbara Jacoby

From: healthline.com The FDA will now require all mammography reports to include whether a person has breast density. Breast density is considered a risk factor for breast cancer and can make it difficult to detect signs of cancer. Dietary and lifestyle modifications may help reduce breast density, but more importantly, they help lower a person’s risk of developing breast cancer. …

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FDA Grants Fast Track Status to AC699 for ER+/HER2–, ESR1-Mutated Breast Cancer

In In The News by Barbara Jacoby

By: Kristi Rosa From:.onclive.com The FDA has awarded fast track designation to the investigation of AC699 as a potential therapeutic option for patients with estrogen receptor (ER)­–positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer that progressed on or following 1 more lines of endocrine-based therapy.1 The orally bioavailable, chimeric ERα degrader is designed to bring an ER ligand to cereblon …

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FDA Approves Tepylute for Breast and Ovarian Cancer Treatment

In In The News by Barbara Jacoby

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 …

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UTD1 Receives FDA Orphan Drug Designation in Breast Cancer Brain Metastasis

In In The News by Barbara Jacoby

By: Ashling Wahner From: onclive.com The FDA has granted orphan drug designation to utidelone injectable (UTD1) as a potential therapeutic option for patients with breast cancer brain metastases, according to an announcement from Biostar Pharma.1 Unlike most macromolecular drugs, utidelone can cross the blood-brain barrier because of its unique physiochemical characteristics and its insusceptibility to P-glycoprotein–mediated efflux. The orphan drug …

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Dr Park on the FDA Vote Supporting Lumisight Use for Breast Cancer Detection During Surgery

In In The News by Barbara Jacoby

By: Ko Un Park, MD From: onclive.com Ko Un “Clara” Park, MD, associate surgeon, Division of Breast Surgery, Director of Research, Breast Surgery Network Sites, Center For Surgery and Public Health, Brigham and Women’s Hospital, member, faculty of surgery, Division of Breast Surgery, Harvard Medical School, discusses the FDA’s positive recommendation for Lumisight (pegulicianine)-based imaging for patients with breast cancer …

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IceCure Medical Receives FDA Response to De Novo Classification Request for Breast Cancer

In In The News by Barbara Jacoby

By: Ice Cure Medical From: prnewswire.com IceCure Medical Ltd. (Nasdaq: ICCM), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that the U.S. Food and Drug Administration (“FDA”) has at this time denied the Company’s De Novo Classification request for breast cancer which was submitted based …