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Amgen AMGN announced that the FDA has approved its KRAS inhibitor, Lumakras (sotorasib), in combination with its anti-EGFR antibody, Vectibix (panitumumab), for treating KRAS G12C-mutated ...
In light of that stance, it seems likely the FDA could demand Amgen perform another confirmatory trial on Lumakras. As for the panelists’ takes, the University of Virginia School of Medicine’s ...
If Amgen can secure full approval for Lumakras ahead of the FDA's 14 December decision date for Mirati's drug, it could close off that route to market and force the company to wait for its own ...
Clinical trial results reported Monday by Amgen may be enough to confirm the U.S. approval of its KRAS-targeting lung cancer drug called Lumakras. But the new data also show lung cancer patients ...
July 12 (Reuters) - Early trial data on Amgen Inc's Lumakras was released on Tuesday by the World Conference on Lung Cancer (WCLC), but meeting organizers decided to hold until Aug. 7 results from ...
Thousad Oaks, California-based Amgen announced the preliminary results for its drug, Lumakras, after Tuesday’s market close. While the results provide additional validation for the drug ...
A U.S. lawmaker is accusing Amgen of “putting profits before patients ... At issue is a medication called Lumakras, which is used to treat non-small cell lung cancer and won conditional ...
Amgen Inc. said it would continue to work closely with the Food and Drug Administration to seek full approval for its Lumakras cancer drug as a treatment for a form of lung cancer, after an ...
Amgen Inc. AMGN announced top-line data from the phase III CodeBreaK 200 study, which evaluated its KRAS inhibitor, Lumakras (sotorasib), for the treatment of non-small cell lung cancer (NSCLC).
LUMAKRAS ® (sotorasib) Demonstrated Delayed Time to CNS Progression, Longer CNS PFS and Higher Intracranial ORR vs Docetaxel in Post-Hoc Analysis of Phase 3 CodeBreaK 200 Trial LUMAKRAS Shows ...