GlaxoSmithKline secured approval from the U.S. FDA for Arzerra (ofatumumab) for patients with a cancer of the blood and bone marrow called chronic lymphocytic leukemia (CLL) that is not controlled with traditional forms of chemotherapy. GSK’s development partner is Genmab A/S of Denmark. Arzerra is clinically similar to Rituxan, from Roche and Biogen Idec (BIIB).
Arzerra is a win for GSK from an agency that is becoming increasing more conservative and has had a tendency of changing protocols mid-trial on companies. The product was approved under the FDA’s special approval process that allows accelerated approval of drugs that have an unmet clinical need. Approval is based on a surrogate endpoint, but the company intends to submit additional data.
Arzerra is a win for GSK from an agency that is becoming increasing more conservative and has had a tendency of changing protocols mid-trial on companies. The product was approved under the FDA’s special approval process that allows accelerated approval of drugs that have an unmet clinical need. Approval is based on a surrogate endpoint, but the company intends to submit additional data.