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In July 2009, the FDA updated the labels of two anti-EGFR monoclonal antibody drugs (panitumumab and cetuximab) indicated for the treatment of metastatic colorectal cancer to include information about KRAS mutations. [14] This was the result of a study, which demonstrated lack of benefit with Panitumumab in patients who carried NRAS mutations. [6]
The efficacy of using sotorasib, in combination with panitumumab, was evaluated in CodeBreaK 300 (NCT05198934), a randomized, open-label, controlled trial in participants with KRAS G12C-mutated mutated metastatic colorectal cancer who previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. [9]
In July 2009, the US Food and Drug Administration (FDA) updated the labels of two anti-EGFR monoclonal antibody drugs indicated for treatment of metastatic colorectal cancer, panitumumab (Vectibix) and cetuximab (Erbitux), to include information about KRAS mutations. [40]
In January, the FDA asked a host of drugmakers including Gilead Sciences, Johnson & Johnson and Novartis to add a boxed warning to their CAR-T cancer therapies, as it received reports of patients ...
Because of this, the Food and Drug Administration (FDA) announced on January 17 that the agency is implementing a new strategy to lower the risk of certain viruses ending up in your berries.
Katie Overby, who works in the FDA's office that conducts scientific reviews before new ingredients are used in the food supply, said her office has lost about 10% of its workforce, including ...
In July 2009, the US Food and Drug Administration (FDA) updated the labels of two anti-EGFR monoclonal antibody drugs (panitumumab (Vectibix) and cetuximab (Erbitux)) indicated for treatment of metastatic colorectal cancer to include information about KRAS mutations. [18]
The first FDA-approved therapeutic monoclonal antibody was a murine IgG2a CD3 specific transplant rejection drug, OKT3 (also called muromonab), in 1986. This drug found use in solid organ transplant recipients who became steroid resistant. [39] Hundreds of therapies are undergoing clinical trials. Most are concerned with immunological and ...