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Amgen gets colorectal cancer okay for KRAS drug
The US regulator has cleared Lumakras (sotorasib) in combination with Amgen's anti-EGFR antibody Vectibix (panitumumab) for adults with KRAS G12C-mutated metastatic colorectal cancer (CRC) who have been previously treated with chemotherapy.
FDA Approves Lumakras with Vectibix in KRAS G12C+ Colorectal Cancer
The FDA has approved Lumakras with Vectibix for adults with KRAS G12C-mutated metastatic colorectal cancer who received chemotherapy.
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) whose disease progressed after chemotherapy.
Amgen’s Lumakras/Vectibix approved by FDA to treat metastatic colorectal cancer
Lumakras (sotorasib) and Vectibix (panitumumab) have been authorised for use in adults with KRAS G12C-mutated metastatic colorectal cancer who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
FDA Approves Amgen’s LUMAKRAS + Vectibix for KRAS G12C-mutated Colorectal Cancer
Approval was based on the pivotal Phase 3 CodeBreaK 300 study.
Amgen: FDA Approves Lumakras (sotorasib) In Combination With Vectibix (panitumumab) For Chemorefractory Kras G12c-mutated Metastatic Colorectal Cancer
Pivotal Study Demonstrated the Combination More Than Doubled Progression-Free Survival Compared to Investigated SOC THOUSAND OAKS, Calif., Jan. 17, 2025 /PRNewswire/
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,
FDA approves new colorectal cancer treatment
THOUSAND OAKS, Calif. - Amgen (NASDAQ:AMGN), a prominent biotechnology company with a market capitalization of $144.8 billion, has received FDA approval for LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) to treat adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC).
healthandpharma
2d
FDA Approves Sotorasib and Panitumumab Combination: Doubling Survival for KRAS G12C-Mutated Colorectal Cancer
The FDA has approved a novel combination therapy using Lumakras® (sotorasib) and Vectibix® (panitumumab) for adults with KRAS ...
1d
FDA APPROVES LUMAKRAS® (SOTORASIB) IN COMBINATION WITH VECTIBIX® (PANITUMUMAB) FOR CHEMOREFRACTORY KRAS G12C-MUTATED METASTATIC C…
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS® (sotorasib) in ...
The Pharma Letter
1d
FDA nod for Lumakras with Vectibix combo for mCRC
The US Food and Drug Administration approved sotorasib (trade name Lumakras) with panitumumab Vectibix), from US biotech ...
Healio
1d
FDA approves therapies for colorectal cancer, mantle cell lymphoma
The FDA approved two oncology regimens on Jan. 16.One is for a subset of patients with colorectal cancer and the other for ...
Targeted Oncology
2d
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 ...
The American Journal of Managed Care
1d
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 ...
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