Breast cancer experts answer key questions on selecting, sequencing, and managing ADCs in HR-positive, HER2-positive, and triple-negative disease.
News|Articles|June 9, 2026
FDA Flashback: Breast Cancer Decisions and News From May 2026
Author(s)Ashling Wahner
Fact checked by: Chris Ryan
Read a refresh of the top FDA news in breast cancer from May 2026, including several key approvals across ER-positive and triple-negative disease.
Advertisement
Advertisement
Catch a glimpse of the breast cancer–related FDA decisions granted in May 2026, including several drug approvals and an updated Prescription Drug User Fee Act (PDUFA) target action date.
Related to this article
The European Commission approved T-DXd for patients with HER2+ breast cancer who have residual invasive disease after neoadjuvant treatment.
Invikafusp alfa plus sacituzumab govitecan produced responses and disease control in metastatic TNBC and HR-positive/HER2-negative breast cancer.
Lirafugratinib was added as a category 2A subsequent-line option for cholangiocarcinoma with an FGFR2 fusion or rearrangement and disease progression.
The FDA granted priority review to an sNDA for zanubrutinib plus rituximab in untreated mantle cell lymphoma.
See what leading breast oncologists have to say about practice-informing data to come out of the 2026 ESMO Congress.
Erica L. Mayer, MD, MPH, discusses the FDA approval of camizestrant for ESR1-mutated HR+/HER2– breast cancer and the importance of ctDNA monitoring.
Phase 3 SAFFRON data support EU and Japanese filings for savolitinib plus osimertinib in EGFR-mutated NSCLC with MET overexpression or amplification.
Advertisement
Advertisement