The US Food and Drug Administration (FDA) announced that it has approved cetuximab as a new indication for colorectal cancer and has approved a genetic test to rule out treatment with KRAS mutations Benefit the patient.
According to the new indication, cetuximab (Erbitux) can be combined with the three-drug FOLFIRI (irinotecan, 5-fluorouracil, and folinic acid) chemotherapy regimen as a metastatic marker for epidermal growth factor receptor (EGFR) expression. In first-line treatment of patients with colorectal cancer, EGFR is a therapeutic target for cetuximab. This indication requires that patients do not have KRAS mutations because cetuximab is not effective in these patients.
At the same time, the FDA approved The Therascreen KRAS RGQ Polymerase Chain Reaction Kit, which provides information on whether metastatic colorectal patients carry KRAS mutations and "can reliably identify these patient subgroups in patients with colon cancer. ". The genetic testing kit produced by Qiagen is a real-time polymerase chain reaction assay that can detect seven different KRAS gene mutations from one tumor specimen.
Dr. Richard Pazdur, director of the Oncology Drug Product Office at the FDA's Center for Drug Evaluation and Research, pointed out: "Approving this new indication of Erbitux and approving genetic tests at the same time can guide clinicians to accurately select patients who may benefit most."
The indications for the cetuximab plus FOLFIRI protocol were approved based on a retrospective analysis of subgroup patients in three trials: the CRYSTAL study and two support studies (CA225025 and EMR 62 202-047 [OPUS]). This analysis determined that the therapeutic benefit of cetuximab "is limited to patients who do not have any of the seven KRAS mutations in the tumor." Cetuximab therapy has been associated with improved overall survival, progression-free survival, and overall response rates in patients with wild-type KRAS tumors, while it has neither benefit nor potential harm in patients with KRAS mutations.
During the CRYSTAL trial open-label period, patients with metastatic colorectal cancer expressing EGFR were treated with FOLFIRI with or without cetuximab. Retrospective analysis showed that 63% of patients were wild-type KRAS tumors, and the remaining 37% carried KRAS mutations. In the wild-type KRAS patients, the median overall survival was 23.5 months in the cetuximab + FOLFIRI group, and only 19.5 months in the FOLFIRI alone group. The median progression-free survival time was also longer in the former (9.5 months). Vs. 8.1 months). In patients with KRAS mutations, the addition of cetuximab failed to significantly improve these two indicators. The CA225025 and OPUS trials added cetuximab based on the best supportive therapy and FOLFOX regimen, respectively. In both studies, the benefit of treatment with cetuximab was limited to those with wild-type KRAS. The safety data of these studies met the adverse reaction characteristics of cetuximab and chemotherapy regimens.
The FDA recommended cetuximab dose and method for the first intravenous infusion of 400 mg/m2, infusion within 120 minutes, after which an intravenous infusion of 250 mg/m2, at least for 30 minutes, weekly combination regimen. It said that cetuximab administration should be completed 1 hour before the program.
Cetuximab (Erbitux, submitted by ImClone) received accelerated approval in 2004 and was approved for treatment of advanced colorectal cancer patients who no longer respond to irinotecan-based chemotherapy. In 2007, the FDA formally approved a single dose of cetuximab “for the treatment of metastatic colorectal cancer patients who have failed irinotecan-based and oxaliplatin-based chemotherapy and have expressed EGFR.†The drug is also approved for the treatment of head and neck cancer.
The approved genetic testing kit was developed by Qiagen, Manchester, United Kingdom. Erbitux is sold by Bristol-Myers Squibb and Lilly. Erbitux is sold by Bristol-Myers Squibb and Lilly.
According to the new indication, cetuximab (Erbitux) can be combined with the three-drug FOLFIRI (irinotecan, 5-fluorouracil, and folinic acid) chemotherapy regimen as a metastatic marker for epidermal growth factor receptor (EGFR) expression. In first-line treatment of patients with colorectal cancer, EGFR is a therapeutic target for cetuximab. This indication requires that patients do not have KRAS mutations because cetuximab is not effective in these patients.
At the same time, the FDA approved The Therascreen KRAS RGQ Polymerase Chain Reaction Kit, which provides information on whether metastatic colorectal patients carry KRAS mutations and "can reliably identify these patient subgroups in patients with colon cancer. ". The genetic testing kit produced by Qiagen is a real-time polymerase chain reaction assay that can detect seven different KRAS gene mutations from one tumor specimen.
Dr. Richard Pazdur, director of the Oncology Drug Product Office at the FDA's Center for Drug Evaluation and Research, pointed out: "Approving this new indication of Erbitux and approving genetic tests at the same time can guide clinicians to accurately select patients who may benefit most."
The indications for the cetuximab plus FOLFIRI protocol were approved based on a retrospective analysis of subgroup patients in three trials: the CRYSTAL study and two support studies (CA225025 and EMR 62 202-047 [OPUS]). This analysis determined that the therapeutic benefit of cetuximab "is limited to patients who do not have any of the seven KRAS mutations in the tumor." Cetuximab therapy has been associated with improved overall survival, progression-free survival, and overall response rates in patients with wild-type KRAS tumors, while it has neither benefit nor potential harm in patients with KRAS mutations.
During the CRYSTAL trial open-label period, patients with metastatic colorectal cancer expressing EGFR were treated with FOLFIRI with or without cetuximab. Retrospective analysis showed that 63% of patients were wild-type KRAS tumors, and the remaining 37% carried KRAS mutations. In the wild-type KRAS patients, the median overall survival was 23.5 months in the cetuximab + FOLFIRI group, and only 19.5 months in the FOLFIRI alone group. The median progression-free survival time was also longer in the former (9.5 months). Vs. 8.1 months). In patients with KRAS mutations, the addition of cetuximab failed to significantly improve these two indicators. The CA225025 and OPUS trials added cetuximab based on the best supportive therapy and FOLFOX regimen, respectively. In both studies, the benefit of treatment with cetuximab was limited to those with wild-type KRAS. The safety data of these studies met the adverse reaction characteristics of cetuximab and chemotherapy regimens.
The FDA recommended cetuximab dose and method for the first intravenous infusion of 400 mg/m2, infusion within 120 minutes, after which an intravenous infusion of 250 mg/m2, at least for 30 minutes, weekly combination regimen. It said that cetuximab administration should be completed 1 hour before the program.
Cetuximab (Erbitux, submitted by ImClone) received accelerated approval in 2004 and was approved for treatment of advanced colorectal cancer patients who no longer respond to irinotecan-based chemotherapy. In 2007, the FDA formally approved a single dose of cetuximab “for the treatment of metastatic colorectal cancer patients who have failed irinotecan-based and oxaliplatin-based chemotherapy and have expressed EGFR.†The drug is also approved for the treatment of head and neck cancer.
The approved genetic testing kit was developed by Qiagen, Manchester, United Kingdom. Erbitux is sold by Bristol-Myers Squibb and Lilly. Erbitux is sold by Bristol-Myers Squibb and Lilly.
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