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Novian Health Gains FDA Breakthrough Designation for Novilase Breast Therapy

In Clinical Studies News by Barbara Jacoby

Groundbreaking laser therapy offers alternative to surgery for breast cancer Novian Health Inc. has been granted Breakthrough Device designation from the U.S. Food and Drug Administration for its Novilase®Interstitial Laser System and its proposed indication for use: the focal destruction of malignant breast tumors in adult women who seek a breast conserving procedure. The FDA’s Breakthrough Device program supports the …

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MacroGenics Announces Final Overall Survival Results from SOPHIA Study of MARGENZA™ in Patients with HER2-Positive Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: MacroGenics From: pipelinereview.com Final overall survival (OS) analysis did not demonstrate a statistically significant advantage for MARGENZA over trastuzumab OS was greater with MARGENZA plus chemotherapy in exploratory subgroups of patients carrying a CD16A 158F allele compared to trastuzumab plus chemotherapy arm, while the OS for trastuzumab plus chemotherapy was greater than MARGENZA plus chemotherapy for the small exploratory …

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G1 Therapeutics Receives Fast Track Designation from U.S. Food and Drug Administration for COSELA™ (Trilaciclib) in Combination with Chemotherapy for the Treatment of Locally Advanced or Metastatic Triple Negative Breast Cancer

In Clinical Studies News by Barbara Jacoby

Source: G1 Therapeutics From: finance.yahoo.com G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to COSELA™ (trilaciclib) investigation for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC). COSELA is currently being evaluated in PRESERVE 2, …

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FDA Supports Continued Development of Oral Paclitaxel/Encequidar in Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Kristi Rosa From: onclive.com Athenex, Inc. held a Type A meeting with the FDA to discuss the deficiencies raised in the complete response letter issued in March 2021 for the new drug application for oral paclitaxel plus encequidar in the treatment of patients with metastatic breast cancer. Athenex, Inc. held a Type A meeting with the FDA to discuss …

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FDA ‘may require’ post-marketing studies to analyze long-term effects of breast cancer drugs

In In The News by Barbara Jacoby

By: Joanne S. Eglovitch From: raps.org  The US Food and Drug Administration (FDA) “may require” or seek agreement from sponsors to conduct post-marketing studies to analyze long term effects of breast cancer drugs in both pre- and post-menopausal women in a final guidance issued on 17 June. The guidance also provides other considerations for sponsors as they plan for the …

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Ascentage Pharma Announces IND Clearance by the US FDA for Lisaftoclax (APG-2575)

In Clinical Studies News by Barbara Jacoby

Source: Ascentage Pharma From: prnewswire.com Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the Investigational New Drug (IND) application for the company’s novel Bcl-2 inhibitor, lisaftoclax (APG-2575), has been cleared by the US Food and Drug Administration (FDA) and the company is …

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FDA Grants Regular Approval to Sacituzumab Govitecan for TNBC

In Clinical Studies News by Barbara Jacoby

From: onclive.com The FDA has granted a regular approval to sacituzumab govitecan (Trodelvy) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have previously received 2 or more systemic therapies, at least 1 of them for metastatic disease. The Trop2-directed antibody and topoisomerase inhibitor drug conjugate was previously granted an accelerated approval in …

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FDA Approval Sought for F-627 for Chemotherapy-Induced Neutropenia in Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Kristi Rosa From: onclive.com A biologics license application has been submitted to the FDA for the approval of F-627 as a treatment option for patients with breast cancer who have chemotherapy-induced neutropenia. A biologics license application has been submitted to the FDA for the approval of F-627 (Ryzneuta; formerly efbemalenograstim alpha) as a treatment option for patients with breast …

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FDA Grants Premarket Approval to Diagnostic Breast Cancer Imaging Technology

In Clinical Studies News by Barbara Jacoby

By: Kristi Rosa From: onclive.com The FDA’s Center for Devices and Radiological Health has granted premarket approval (PMA) to diagnostic breast cancer imaging technology developed by Seno Medical Instruments to assist in the differentiation between benign and malignant breast lesions in patients.1 By using noninvasive poto-acoustic ultrasound technology, the Imagio Breast Imaging System is able to produce data on suspicious …

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FDA grants fast track designation to ARX788 for breast cancer subset

In In The News by Barbara Jacoby

Source: HemOnctoday From: healio.com The FDA granted fast track designation to ARX788 as monotherapy for certain patients with HER2-positive breast cancer. The designation applies to use of the agent for patients with advanced or metastatic disease who received at least one prior anti-HER2-based regimen in the metastatic setting. ARX788 (Ambrx) — an antibody-drug conjugate that targets the HER2 receptor — …