Amgen responds to FDA warning letter about Vectibix promo video

Genentech/Roche's investigational drug divarasib showed improved overall survival and progression-free survival in KRAS G12C-mutated NSCLC patients compared to standard treatments sotorasib (Amgen) and adagrasib (Bristol Myers Squibb). The phase 3 Krascendo 1 trial results, presented at ESMO Congress, indicated a 44% lower risk of death with divarasib, along with fewer severe adverse effects.

Amgen (AMGN) reported that its cancer treatment Imdelltra, when combined with AstraZeneca's Imfinzi, reduced death risk by 58% in late-stage lung cancer patients. Imdelltra's sales grew 115% to $288M in H1 2026. Amgen's stock is up 40% YTD, with 22 products showing double-digit growth in Q2. The company's forward P/E is 19, in line with the S&P 500 average.

Amgen is advancing its experimental obesity drug, maridebart cafraglutide (MariTide), into Phase 3 trials. The drug, developed using genomic data from Iceland, aims to compete with weekly injectables like semaglutide and tirzepatide. Phase 2 results showed up to 20% weight loss over 52 weeks. Amgen's approach differs by blocking the GIP receptor, contrasting with competitors' strategies. The global obesity drug market is projected to exceed $120 billion annually by 2030.

Pharmaceutical companies like Samsung Bioepis, Formycon, Zydus, Celltrion, and Amgen are racing to develop biosimilars for MSD's top-selling cancer drug Keytruda, as its patent nears expiration. Samsung Bioepis filed for FDA approval, while Formycon and Zydus are already under review. MSD is defending its market with a new subcutaneous formulation, Keytruda Qlex, and plans to acquire new drugs.

AstraZeneca's IMFINZI combined with Amgen's tarlatamab-dlle extended median survival to 21.1 months in extensive-stage small cell lung cancer patients, compared with 12.7 months for IMFINZI alone, according to Phase III trial results. The combination reduced the risk of death by 58% and disease progression by 66%. The findings were presented at the European Society for Medical Oncology Congress 2026 and published in The New England Journal of Medicine.

FDA proposed withdrawing Tavneos' US approval due to safety concerns and trial data issues, citing severe liver injuries and insufficient effectiveness evidence. Amgen, which acquired ChemoCentryx, disputes the FDA's claims, arguing that data reassessment corrected errors and real-world data supports the drug's benefits. The FDA may hold a public hearing before making a final decision.