FDA Approves Biweekly Dosing for ImClone’s Cancer Drug Erbitux
The FDA has approved a new, biweekly dosing regimen for ImClone’s cancer drug, Erbitux (cetuximab), for patients with a certain form of EGFR-expressing colorectal cancer or head and neck squamous-cell carcinoma.
The approval revises the agency’s previous authorization for a weekly dosage of the drug when used as a monotherapy or in combination chemotherapy, so dosing of 500 mg every two weeks is now allowed.
The FDA said it granted the approval based on progression-free survival and overall survival rates from studies of cancer patients and real-world data.
ImClone is an oncology-focused subsidiary of Eli Lilly acquired in 2008 for $6.5 billion.