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
Pharma & Biotech
Can Chipscreen’s AI-discovered CS43158 overcome leukemia drug resistance? China clears human trials
Chipscreen secures China IND clearance for CS43158, targeting FLT3 mutations and resistance pathways in acute myeloid leukemia.
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.
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
Nuvation Bio’s safusidenib gets FDA Fast Track, but Phase 3 SIGMA remains the decisive test
FDA Fast Track designation could increase regulatory interaction around safusidenib while Nuvation Bio tests the IDH1 inhibitor across several glioma settings.
Pharma & Biotech
What Innovent Biologics’ VANFLYTA deal means for FLT3-ITD AML treatment in China
Innovent Biologics will commercialize Daiichi Sankyo’s VANFLYTA in China after its June approval for newly diagnosed FLT3-ITD AML.
Pharma & Biotech
Datroway EU approval expands first-line treatment options for metastatic triple-negative breast cancer
EU approval moves Datroway into first-line metastatic TNBC after TROPION-Breast02 showed survival gains, intensifying the TROP2 ADC race.
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.
Pharma & Biotech
Why American Regent’s single-lot papaverine recall carries a potentially serious injectable safety risk
American Regent recalls one papaverine injection lot after glass or paraformaldehyde particles were found, raising serious injectable safety concerns.