Amgen wins FDA nod for Lumakras

Amgen wins FDA nod for Lumakras as a drug combo for colorectal cancer
The U.S. Food and Drug Administration (FDA) has approved Amgen’s (NASDAQ:AMGN) KRASG12C inhibitor Lumakras as part of a combination regimen for adults with metastatic colorectal cancer (mCRC) whose tumors harbor an abnormal gene known as KRAS G12C.
Looking Beyond Obesity, Amgen Wins Colorectal Cancer Expansion for Lumakras
The Phase III CodeBreaK 300 study returned disappointing overall survival data for Lumakras plus Vectibix in metastatic colorectal cancer, but in its approval announcement, the FDA pointed to significant improvements in progression-free survival,
FDA Approves Amgen Treatment For Pretreated Colorectal Cancer With Certain Mutation
The Food and Drug Administration approved Amgen Inc ‘s AMGN Lumakras (sotorasib) in combination with Vectibix (panitumumab) for KRAS G12C-mutated metastatic colorectal cancer (mCRC), who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan- based chemotherapy .
Amgen's Lumakras, Vectibix Net FDA Approval in KRAS G12C-Mutant Colorectal Cancer
The FDA also approved Qiagen's Therascreen KRAS RGQ PCR kit as a companion diagnostic to identify KRAS G12C-mutant patients.
FDA Approves Amgen’s LUMAKRAS + Vectibix for KRAS G12C-mutated Colorectal Cancer
Approval was based on the pivotal Phase 3 CodeBreaK 300 study.
Amgen's Lumakras+Vectibix Combo Gets FDA Approval For Metastatic Colorectal Cancer Treatment
Friday announced that the U.S. Food and Drug Administration has approved its Lumakras plus Vectibix combination
US FDA approves Amgen's colorectal cancer therapy
The U.S. Food and Drug Administration approved Amgen's combination therapy on Thursday to treat colorectal cancer in patients with a specific gene mutation. Amgen's Lumakras in combination with Vectibix was approved to treat adult patients whose cancer has spread to other parts of the body despite receiving chemotherapy,
The American Journal of Managed Care1d
FDA Approves Sotorasib Plus Panitumumab for KRAS G12C-Mutated Metastatic CRC
The combination treatment specifically targets KRAS-mutated metastatic colorectal cancer (CRC) to improve progression-free ...
Pharmaceutical Technology13d
Sotorasib by Amgen for Solid Tumor: Likelihood of Approval
Sotorasib is under clinical development by Amgen and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 37% phase transition success rate (PTSR) ...
oncnursingnews2d
Sotorasib Plus Panitumumab Receives FDA Approval for KRAS G12C–Mutated Colorectal Cancer
The FDA has approved sotorasib with panitumumab for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC) ...
Targeted Oncology2d
FDA Oks Sotorasib/Panitumumab in KRAS G12C-Mutant Colorectal Cancer
The FDA has approved the combination of sotorasib (Lumakras) and panitumumab (Vectibix) for the treatment of patients with ...
C&EN2y
The Discovery of Sotorasib (AMG 510): First-in-Class Investigational Covalent Inhibitor of KRAS G12C
Join Brian Lanman of Amgen as he outlines the strategies used to overcome these challenges, the screening approaches employed to identify starting points for these efforts, and the optimization ...