The FDA approval brings CDK4/6 inhibition into HR-positive, HER2-positive metastatic breast cancer maintenance, although toxicity, immature survival data and a rapidly changing first-line market could shape adoption.
Imagion Biosystems has converted FDA permission to proceed into funding for a Phase 1b/2 test of whether targeted MRI can improve HER2-positive breast cancer staging.
ENHERTU is moving earlier in breast cancer care. The bigger question is whether efficacy gains can outweigh ADC safety scrutiny.
DualityBio’s trastuzumab pamirtecan has entered China review for HER2-positive breast cancer. Read what this filing could change next.
Innovent Biologics advances IBI354 into phase 3 first-line HER2-positive breast cancer. Find out what this means for ADC competition and clinical practice.
Discover how ALX Oncology’s CD47 biomarker data could reshape immuno-oncology strategies and what risks still stand for evorpacept.
NERLYNX launches in Thailand for HER2+ breast cancer. Find out how neratinib could reshape relapse prevention and treatment sequencing across Southeast Asia.
KORU Medical’s 510(k) filing for FreedomEDGE with PHESGO could reshape subcutaneous cancer therapy. Find out what this means for oncology care delivery.
AstraZeneca PLC and Daiichi Sankyo’s HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for use in patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment and are at high risk of recurrence. The designation is based on positive results
KORU Medical’s FDA filing to clear FreedomEDGE for PHESGO delivery could reshape cancer infusion workflows. Find out what it means for oncology care.