By:Sara A. Hurvitz, MD, Sabrina Seran From: targetedonc.com On July 14, 2026, the FDA approved gedatolisib (Revtorpyk) in combination with fulvestrant (Faslodex), with or without palbociclib (Ibrance), for adults with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation, based on results from Study 1 of the phase 3 VIKTORIA-1 trial (NCT05501886).1 Gedatolisib is the …
First-in-class Protein Degrader Approved for ESR1-mutated Breast Cancer
From: aacr.org/patients-com Vepdegestrant is the first PROTAC approved for any cancer indication. The U.S. Food and Drug Administration (FDA) approved vepdegestrant (Veppanu) for adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer with a mutation in the gene ESR1 that has progressed after at least one prior line of endocrine therapy. Concurrently, …
FDA Approves Gedatolisib Plus Fulvestrant ± Palbociclib for Hormone Receptor–Positive, HER2-Negative, Locally Advanced/Metastatic Breast Cancer
By: Ashling Wahner From: onclive.com Key Takeaways Indication targets endocrine-pretreated metastatic HR-positive/HER2-negative disease specifically without PIK3CA mutations, positioning therapy for patients ineligible for PI3Kα-mutant–directed strategies. Triplet therapy with gedatolisib/fulvestrant/palbociclib produced median PFS 9.3 months versus 2.0 months with fulvestrant alone, yielding an adjusted hazard ratio of 0.24. Doublet gedatolisib plus fulvestrant demonstrated median PFS 7.4 months and significant risk reduction …
FDA Approves Palbociclib for HR+/HER2+ Metastatic Breast Cancer Maintenance
From: oncnursingnews.com On June 24, the U.S. Food and Drug Administration (FDA) announced the approval of palbociclib (Ibrance) for a new indication in the oncology space. This approval specifically covers palbociclib in combination with trastuzumab (Hercdptin), with or without pertuzumab (Perjeta), and endocrine therapy for the maintenance treatment of adults with hormone receptor (HR)-positive, HER2-positive locally advanced or metastatic breast …
FDA Approves Datopotamab Deruxtecan for Unresectable or Metastatic TNBC
By: Caroline Seymour From: onclive.com The FDA has approved datopotamab deruxtecan-dlnk (Datroway; Dato-DXd) for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.1 The approval is based on findings from the phase 3 TROPION-Breast02 trial (NCT05374512) which demonstrated a statistically significant and clinically meaningful improvement in median overall …
FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
From: .fda.gov On May 15, 2026, the Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo, Inc.) for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II …
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 …
Inluriyo Approved for ER+, HER2-, ESR1-Mutated Metastatic Breast Cancer
By: Jaymin Kang, PharmD approvFrom: oncologynurseadvisor.com The Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant) for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least 1 line of endocrine therapy. The approval was based on data from the randomized, open-label, active-controlled, …
FDA approves Datroway for HR-positive, HER2-negative breast cancer
By: Lori Solomon From: medicalxpress.com The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The Trop-2-directed antibody and topoisomerase inhibitor conjugate is approved for patients who have had disease progression with prior endocrine-based therapy and chemotherapy for unresectable or …
FDA Expands Enhertu Approval to HER2-Ultralow Breast Cancer
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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