Merck Requests Re-examination Of CHMP Opinion For Erbitux

Germany-based Merck has requested re-examination of the negative opinion from the Committee for Medicinal Products for Human Use (CHMP). It is for the use of Erbitux (cetuximab) in combination with platinum-based chemotherapy, for the first-line treatment of patients with non-small cell lung cancer (NSCLC). The company said that taking the opinion seriously, it will work closely with the CHMP to unravel the value of Erbitux for patients benefit.

The decision to request re-examination follows consultation with key stakeholders in the NSCLC treatment community, coupled with Merck’s confidence in the clinical data supporting Erbitux in this potential indication.

The company had earlier presented the FLEX study to the committee. In the randomized, multinational, phase III FLEX study, the overall survival was significantly prolonged for patients receiving Erbitux in first-line therapy.

The FLEX study included 1,125 patients comprising all histological NSCLC subtypes, who received either standard platinum-based chemotherapy plus Erbitux, or chemotherapy alone. Adding Erbitux to chemotherapy significantly prolonged median overall survival regardless of histology, as compared to chemotherapy alone (11.3 vs. 10.1 months, respectively; p=0.04).

Across the study population, the addition of Erbitux to platinum-based chemotherapy was tolerated with manageable side effects, said the company.