Class Labeling Recognizes KRAS as a Predictive Biomarker for anti-EGFr Antibody Monotherapy in Metastatic Colorectal Cancer Results from First Pivotal Trials Prospectively Evaluating KRAS Utility in Combination Therapy Expected In Third Quarter 2009
THOUSAND OAKS, Calif.,
"We are pleased that the FDA has recognized the clinical importance of
KRAS as a predictive biomarker for anti-EGFr antibody therapy," said
The INDICATION AND USAGE section of the prescribing information has been updated to include that retrospective subset analyses of metastatic colorectal cancer trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Vectibix is not recommended for the treatment of colorectal cancer with these mutations.
The CLINICAL STUDIES section of the prescribing information has been updated to reflect results from retrospective analyses across seven randomized clinical trials with agents in this class. This includes the first Phase 3 analysis that showed mCRC patients with mutated KRAS tumors do not respond to monotherapy with an EGFr-inhibiting antibody (the Vectibix "408" trial).
"With this label update, physicians can now eliminate anti-EGFr antibodies
as a treatment option for patients with mutated KRAS tumors and redirect those
patients to alternative therapies, avoiding unnecessary treatments in patients
who are unlikely to benefit," said
This label update is specific to the utility of KRAS as a biomarker for Vectibix used as a monotherapy. In the combination chemotherapy setting, the Vectibix "181" and "PRIME (203)" trials will be the first prospective Phase 3 clinical studies testing the clinical utility of KRAS as a predictive biomarker in mCRC patients in earlier lines of therapy. Data from the "181" and "PRIME (203)" trials are expected in the third quarter of 2009.
This update follows recent KRAS related action from key cancer
organizations, including the
About Colorectal Cancer
Colorectal cancer is the third most common cancer diagnosed in men and in
women in the
Vectibix is indicated as a single agent for the treatment of patients with epidermal growth factor receptor (EGFr)- expressing metastatic colorectal carcinoma after disease progression on, or following fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens. The effectiveness of Vectibix as a single agent for the treatment of EGFr-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data 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 less than or equal to 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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Arvind Sood: 805-447-1060 (investors)