By: Roman Fabbricatore From: cancernetwork.com The FDA issued a “Study May Proceed” letter for a new study investigating oral (Z)-endoxifen in patients with metastatic breast cancer, according to a news release from the developer, Atossa Therapeutics.1 The subject of a recent investigational new drug (IND) application, the ongoing study aims to provide a new therapeutic strategy for patients with estrogen …
FDA Approves T-DXd Plus Pertuzumab for HER2-Positive Breast Cancer
By: Paige Britt From: targetedonc.com Key Takeaways The FDA approved T-DXd plus pertuzumab for HER2-positive metastatic breast cancer, based on DESTINY-Breast09 trial results. The combination therapy reduced disease progression or death risk by 44% compared to the standard regimen. Median progression-free survival was 40.7 months, with an overall response rate of 85.1% for T-DXd plus pertuzumab. The safety profile of …
First Biosimilar for Pertuzumab Approved for HER2-positive Breast Cancer
Source: aacr.org The U.S. Food and Drug Administration (FDA) has approved pertuzumab-dpzb (Poherdy) as a biosimilar to pertuzumab (Perjeta) for certain adults with HER2-positive breast cancer. Pertuzumab-dpzb may be used in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer who have not received anti-HER2 therapy or chemotherapy in the metastatic setting. Pertuzumab-dpzb may also be used …
FDA approves new interchangeable biosimilar to Perjeta
From: fda.gov On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta. Poherdy is a HER2/neu receptor antagonist indicated for the following: use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic …
FDA is Removing the “Black Box” Warnings of Breast Cancer from Menopausal Hormone Therapy Products
By: Nare Hovhannisyan, MD From: oncodaily.com Dr. Marty Makary and Robert F. Kennedy Jr. commend a landmark FDA decision following expert review and global broadcast. In a major policy shift with far-reaching implications for women’s health, the U.S. Food and Drug Administration (FDA) has announced the removal of the long-standing “black box” warnings that associated menopausal hormone therapy (MHT) products …
FDA Says Yes to Cryoablation for Early Breast Cancer
By: Mike Basset From: medpagetoday.com The FDA granted marketing authorization for the ProSense Cryoablation Systemfor small, early-stage breast cancer in older women not suitable for surgery, maker IceCure announced. A minimally invasive tool that destroys tumors by freezing them, the device is indicated for women 70 years and older who have biologically low-risk tumors, no larger than 1.5 cm, and …
New Oral SERD Approved for Certain Estrogen Receptor-mutated Breast Cancers
From:aacr.org The FDA has approved imlunestrant for certain patients with advanced ESR1-mutated breast cancer that has progressed following previous endocrine therapy. The U.S. Food and Drug Administration (FDA) has approved imlunestrant (Inluriyo) for the treatment of adult patients with advanced or metastatic breast cancer that expresses the estrogen receptor (ER), does not overexpress human epidermal growth factor receptor 2 (HER2), …
FDA issues updated guidance on reporting breast density
From: auntminnie.com The U.S. Food and Drug Administration (FDA) has issued updated guidance regarding how breast density should be communicated to patients in a mammography exam report. The approved alternative standard is 21 CFR 900.12(c), and directs radiologists to use the following language to classify breast density: (A) The breast is almost entirely fatty. (B) There are scattered areas of …
T-DXd Granted Breakthrough Therapy Designation by FDA in HER2+ Breast Cancer
By: Roman Fabbricatore From: .cancernetwork.com The FDA has granted fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) breakthrough therapy designation as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer, according to a news release from the drug’s developer, Daiichi-Sankyo.1 Based on results from the phase 3 DESTINY-Breast09 trial (NCT04784715), the agency’s decision follows data presented during a late-breaking oral …
FDA Grants Breakthrough Therapy Designation to Frontline T-DXd Plus Pertuzumab in HER2+ Metastatic Breast Cancer
By: Chris Ryan From: onclive.com he FDA has granted breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in combination with pertuzumab for the first-line treatment of adult patients with HER2-positive unresectable or metastatic breast cancer. The designation was supported by data from the phase 3 DESTINY-Breast09 trial (NCT04784715). “This breakthrough therapy designation provides further recognition of the potential benefit of …