Amgen wins FDA nod for Lumakras

Amgen wins FDA nod for Lumakras as a drug combo for colorectal cancer
Amgen (AMGN) stock in focus as U.S. approval for its lung cancer drug expands for metastatic colorectal cancer. Read more here.
FDA Approves Amgen Treatment For Pretreated Colorectal Cancer With Certain Mutation
The CodeBreaK 300 results demonstrated that Lumakras 960 mg daily plus Vectibix (n=53) showed an improved median progression-free survival (PFS) of 5.6 months compared to 2 months on the investigator’s choice of care (n=54).
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,
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
FDA Greenlights Amgen's New Cancer Drug Combo, Boosting Survival for KRAS G12C Patients
Lumakras, primarily known for lung cancer treatment, became the first FDA-approved KRASG12C inhibitor in 2021 for non-small cell lung cancer. Amgen continues expanding its use, aiming to address cancers driven by the same genetic mutation.
FDA Approves Amgen’s LUMAKRAS + Vectibix for KRAS G12C-mutated Colorectal Cancer
Approval was based on the pivotal Phase 3 CodeBreaK 300 study.
Amgen announces FDA approval of Lumakras in combination with Vectibix
Amgen (AMGN) announced that the U.S. FDA has approved Lumakras in combination with Vectibix for the treatment of adult patients with KRAS
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 LUMAKRAS® (SOTORASIB) IN COMBINATION WITH VECTIBIX® (PANITUMUMAB) FOR CHEMOREFRACTORY KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC),
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.
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AstraZeneca's Calquence and Amgen's Lumakras clinch FDA label expansions
Amgen’s Lumakras and AstraZeneca’s Calquence are both in line to expand their respective oncology reaches with new FDA ...
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Af­ter three-month de­lay, Am­gen’s Lumakras clinch­es FDA green light in col­orec­tal can­cer
FDA approves Amgen's Lumakras with Vectibix for metastatic colorectal cancer with KRAS G12C mutation, based on Phase 3 ...