By: Liz Highleyman From: cancerhealth.com The Food and Drug Administration (FDA) recently approved several new therapies for breast cancer, including for patients with metastatic (Stage IV) cancer and hard-to-treat triple-negative breast cancer (TNBC). Because treatment is continually evolving, it is often possible to move on to new medications if current ones stop working. Breast cancer, classified by the type of …
Gedatolisib Combinations Nearly Double PFS in PIK3CA-Mutant Breast Cancer
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 new therapy for double-positive metastatic breast cancer
Source: Dana-Farber Cancer Institute From news-medical.net The U.S. Food and Drug Administration (FDA) has approved a new therapy regimen for patients with “double-positive” metastatic breast cancer based on results of the phase 3 PATINA study led by Otto Metzger, MD, Associate Medical Director of International Strategic Initiatives at Dana-Farber Cancer Institute. The PATINA trial demonstrated that the addition of the CDK 4/6 …
FDA Approvals for Metastatic TNBC: 2 New Options Explained
From: oncodaily.com For years, first-line treatment for metastatic triple-negative breast cancer has been shaped by a difficult divide. Patients whose tumors express PD-L1 and are eligible for immunotherapy may receive checkpoint blockade with chemotherapy. For patients who are not candidates for PD-1 or PD-L1 inhibitor-based therapy, chemotherapy has remained the principal first-line option. Two recent FDA actions have changed that …
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 …
Yale-led technology receives FDA approval for breast cancer treatment
By: Meg Dalton From: yale.edu More than a decade ago, Yale chemist Craig Crews founded a biotechnology company in New Haven based on his pioneering research into PROTACs (or PROteolysis TArgeting Chimera), a technology that treats certain types of cancer and other diseases by degrading the proteins that cause them. That company, Arvinas, has since developed a PROTAC therapy called vepdegestrant, …