Merck asks EMEA to re-examine negative opinion of Erbitux cancer drug
Merck KGaA has requested re-examination of the negative opinion from CHMP for the use of Erbitux
Merck KGaA has requested re-examination of the negative opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), 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).
Merck submitted an application to EMEA to license Erbitux for first-line treatment of NSCLC in September 2008. The CHMP opinion was published on July 24, 2009. Erbitux is currently a first-line treatment for both metastatic colorectal cancer (mCRC) in patients with KRAS wild-type tumours and squamous cell carcinoma of the head and neck (SCCHN).
CHMP said "modest" benefits for the proposed wider use of the drug "did not outweigh its risks" and recommended that the change to the marketing authorisation be refused.
Erbitux is one of Merck's top three products with Rebif and Gonal-f, which accounted for half of total sales during the second quarter at Merck Serono, the group's pharmaceutical division.
Merck says it will work closely with the CHMP to "unravel the value of Erbitux for patients" benefit".