Oncology Biomarker KRAS to be Discussed at FDA Panel Meeting
KRAS Biomarker Presents Potential to Personalize Colorectal Cancer Treatment Determining Who Can Benefit from Vectibix(R)
We believe that data shared with the Committee support the suggestion that KRAS is a predictive biomarker for the anti-EGFr class of drugs in the monotherapy setting. In
“These data are consistent with 30 years of biology which indicate that KRAS is a clinically relevant oncogene,” said
To further independently evaluate the association of KRAS status seen in the “408″ trial, additional retrospective analyses of all other studies of Vectibix monotherapy in mCRC were performed. A pooled analysis, presented at the European Society of Medical Oncology in 2008 from over 700 patients (including subjects randomized to Vectibix in “408″) will be presented to the Committee for their consideration.
Data that KRAS is a clinically relevant biomarker for Vectibix is confined to the monotherapy setting; there is not yet sufficient data with Vectibix in combination with chemotherapy to conclude that KRAS is a valid predictive biomarker in that setting. However, pivotal studies “181″ and “PRIME (“203″) will be the first prospective Phase 3 clinical studies to test the effect of Vectibix in wild-type KRAS tumors in combination with chemotherapy and to determine the clinical utility of KRAS as a predictive biomarker in mCRC. Data from these trials will be available in 2009.
“Based on available data, we believe that focusing Vectibix treatment on patients with wild-type KRAS tumors will avoid unnecessary adverse events in patients who are unlikely to benefit, maximize response rates and PFS in patients with wild-type KRAS genes, and redirect patients with a mutated KRAS gene to alternative therapies,” said
In November, the National Comprehensive Cancer Network (NCCN) announced updates to their Guidelines on Colon and Rectal Cancers that included the recommendation that a determination of the KRAS gene status of either the primary tumor or a site of metastasis should be part of the pre-treatment work-up for patients diagnosed with metastatic colorectal cancer. Further, the guidelines recommended that EGFr inhibitors, including Vectibix, should only be used in patients with tumors characterized by the wild-type KRAS gene.
“Amgen is applying the use of cutting-edge science and technology to attempt to target therapies to patients most likely to receive benefit,” said
For more information on biomarkers and their potential role in the future of cancer treatment, prevention and detection, please visit http://www.amgen.com/media/virtual_press_kits.html.
About Colorectal Cancer
Colorectal cancer is the third most common cancer diagnosed in men and in women in
Vectibix is indicated for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens. The effectiveness of Vectibix for the treatment of EGFr-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Important Product Safety Information
Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 and higher) in 12 percent of patients receiving Vectibix monotherapy. Withhold Vectibix for dermatologic toxicities that are grade 3 or higher or are considered intolerable. If toxicity does not improve to Ã¢“°Â¤ grade 2 within 1 month, permanently discontinue Vectibix. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Subsequent to the development of severe dermatologic toxicities, infectious complications, including sepsis, septic death, and abscesses requiring incisions and drainage were reported.
Infusion Reactions: Severe infusion reactions occurred in approximately 1 percent of patients. Severe infusion reactions included anaphylactic reactions, bronchospasm, and hypotension. Although not reported with Vectibix, fatal infusion reactions have occurred with other monoclonal antibody products. Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue Vectibix.
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