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Newly Approved Lumakras (sotorasib) Fights Lung Cancer Tied to Certain Genes drugs
June 07, 2021
A newly approved lung cancer drug shows promise in improving survival in patients whose tumors carry a common and tough-to-treat genetic mutation, researchers say.
FDA Grants Sotorasib Priority Review Designation for Advanced, Metastatic NSCLC americanpharmaceuticalreview
February 19, 2021
Amgen announced the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) ...
Sotorasib shows success against non-small cell lung cancer in Phase II trial europeanpharmaceuticalreview
February 01, 2021
In a Phase II trial, sotorasib was shown to be effective against pre-treated non-small cell lung cancer (NSCLC).
Amgen Submits Sotorasib Marketing Authorization Application to EMA americanpharmaceuticalreview
December 28, 2020
Amgen announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, an investigational KRASG12C inhibitor, for the treatment of adult patients with previously treated KRAS G12C-mutated ...
Amgen files KRAS inhibitor sotorasib with EMA pharmatimes
December 24, 2020
Amgen has submitted a marketing authorisation application the European Medicines Agency (EMA) for its investigational KRAS inhibitor sotorasib for previously-treated KRAS G12C-mutated non-small cell lung cancer (NSCLC).
Amgen’s sotorasib gets FDA breakthrough therapy status to treat advanced KRAS G12C-mutant NSCLC pharmaceutical-business-review
December 10, 2020
Amgen has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for its sotorasib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation.