The FDA has granted accelerated approval to Bayer's Hyrnuo as a frontline therapy in HER2-mutant lung cancer, matching rival zongertinib's response rates while carrying twice-daily meal requirements and steeper gastrointestinal toxicity.
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KRAS sat on the undruggable list for decades. Silexion's SIL204 is built to silence the mutation earlier in the cell, and the Phase 2/3 program is now moving into patients.
Novartis said pelacarsen lowered Lp(a) in patients already on guideline-directed care, but Lp(a)HORIZON missed its cardiovascular composite versus placebo. The first large outcomes test of the inherited risk factor now hangs over later trials from Amgen and Lilly.
AbbVie's etentamig beat older salvage on response and progression-free survival in Phase 3 CERVINO. The harder question is whether a single step-up and monthly intravenous schedule can loosen the REMS-and-hospitalization architecture that still gates approved BCMA T-cell engagers.