Triple-Negative Breast Cancer
Jun 26, 2026
TRODELVY’s First-Line TNBC Approval: Gilead’s Big Bet Reshapes the TROP2 ADC Battlefield
Summary TRODELVY redefines first-line mTNBC treatment as the only approved ADC independent of PD-L1 expression. TRODELVY sets a new standard as Europe’s first ADC and first novel therapy in two decades for eligible patients with first-line metastatic triple-negative breast cancer. Approval was based on AS...
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May 26, 2026
US Greenlight for Datroway Marks First TROP2 ADC Approval in Frontline mTNBC Beyond PD-1/PD-L1 Candidates; Gilead’s Hepcludex Achieves Historic FDA Approval Milestone in Chronic HDV; Biogen and Denali Therapeutics Report Progress in Phase 2b Evaluation of BIIB122 for Parkinson’s Disease; Eli Lilly and Company Spotlights Foundayo’s Late-Stage Success in Obesity Studies; BioMarin Shares Successful Phase 3 Study Outcomes for VOXZOGO® in Children with Hypochondroplasia
US Approves Datroway as the First TROP2-directed ADC for 1L mTNBC Patients Unsuitable for PD-1/PD-L1 Therapy AstraZeneca and Daiichi Sankyo have secured US approval for Datroway for treating adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are ineligible for PD-1/PD-L1 inhibitor th...
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Feb 10, 2026
Sanofi Advances wAIHA Program as Rilzabrutinib Receives Breakthrough and Orphan Status; Lilly Moves to Acquire Orna Therapeutics, Expanding Cell Therapy Portfolio; Roche Announces Key PPMS Trial Success for Fenebrutinib; Priovant’s Brepocitinib Demonstrates Strong Potential in Phase 2 Cutaneous Sarcoidosis Study; AstraZeneca’s DATROWAY Grants US Priority Review for 1L mTNBC Indication in Patients not Eligible for Immunotherapy
Sanofi’s Rilzabrutinib Granted Breakthrough and Orphan Designations for wAIHA Rilzabrutinib (WAYRILZ) by Sanofi (EPA: SAN) recently achieved two major regulatory milestones: FDA Breakthrough Therapy Designation in the U.S. and Orphan Drug Designation by the Japanese Ministry of Health, Labour and Welfare for the...
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May 27, 2025
Gilead’s TRODELVY Shows PFS Benefit in 1L Metastatic TNBC; Otsuka’s Sibeprenlimab Gets FDA Priority Review for IgA Nephropathy; Liquidia Wins FDA Nod for YUTREPIA in PAH and PH-ILD; GSK’s BLENREP Combos Get CHMP Backing in Myeloma; Relief Therapeutics Receives FDA Rare Pediatric Disease Tag for RLF-TD011
Gilead’s TRODELVY Demonstrates Significant PFS Benefit in First-Line Metastatic TNBC in ASCENT-03 Trial Gilead Sciences has announced positive topline results from the Phase III ASCENT-03 trial of TRODELVY (sacituzumab govitecan-hziy) in first-line metastatic triple-negative breast cancer (mTNBC) patients who ar...
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