Enhertu cut breast cancer recurrence risk by 53% against T-DM1, but will lung toxicity affect its use?
Enhertu wins EU approval after cutting invasive recurrence or death risk by 53% versus T-DM1. Lung toxicity remains a key consideration.
Pharma & Biotech
Features & Analysis
Pfizer TUKYSA gains FDA approval for first-line HER2-positive metastatic breast cancer maintenance
Pfizer’s TUKYSA gained first-line HER2-positive breast cancer maintenance approval after extending median PFS by 8.6 months.
Pharma & Biotech
Pfizer takes Tukysa into first-line HER2+ breast cancer maintenance after 8.6-month PFS gain
FDA approval moves Pfizer’s Tukysa into first-line maintenance for HER2-positive metastatic breast cancer after the regimen extended median progression-free survival from 16.3 to 24.9 months, although severe hepatotoxicity has emerged as an important treatment consideration.
Pharma & Biotech
AstraZeneca’s Enhertu cuts progression risk 37% in first-line HER2-mutant lung cancer as survival question remains open
Enhertu reduced the risk of progression or death by 37% against pembrolizumab plus chemotherapy in first-line HER2-mutant metastatic non-small cell lung cancer, potentially opening another earlier-treatment market for AstraZeneca and Daiichi Sankyo.
Features & Analysis
HYRNUO reached untreated HER2-mutant NSCLC before its Phase 3 answer. What does Bayer need to prove next?
The FDA has expanded HYRNUO into first-line advanced HER2-mutated non-small cell lung cancer after a 75% response rate in an early-phase cohort. The approval gives Bayer an important head start, but rival oral therapies and unfinished confirmatory trials mean the long-term treatment hierarchy remains unsettled.
Pharma & Biotech
Europe’s HER2 breast cancer standard stood for more than a decade. Enhertu just broke through
The European Commission has approved AstraZeneca and Daiichi Sankyo’s Enhertu with pertuzumab for first-line HER2-positive metastatic breast cancer after DESTINY-Breast09 showed a 44% reduction in the risk of progression or death compared with long-standing THP therapy.
Pharma & Biotech
Why Enhertu’s EU recommendation could end a decade of stability in first-line HER2 breast cancer treatment
EU regulators back Enhertu plus pertuzumab for first-line HER2-positive metastatic breast cancer, shifting focus to approval, safety and access.
Features & Analysis
Avacta previews AVA6103 pharmacokinetic data as sustained-release cancer drug faces first human test
Avacta’s next AVA6103 data will test sustained exatecan release in cancer patients. Read what the FOCUS-01 results could mean for its platform.
Medical Devices & Diagnostics
Enhertu wins EU tumor-agnostic approval, but HER2 testing will decide its real impact
The European approval takes Enhertu beyond organ-specific oncology, although its clinical reach will depend on reliable HER2 testing, reimbursement and safety management.
Pharma & Biotech
Enhertu nears wider EU approval as HER2 testing moves deeper into solid tumor oncology
Find out how Enhertu’s EU recommendation could reshape HER2 targeted treatment for metastatic solid tumors.