First-line Erbitux with FOLFOX or FOLFIRI approved in China for RAS wild-type mCRC

German pharma and sciences firm Merck KGaA (MRK: DE says that Erbitux (cetuximab) has been granted approval by China’s National Medical Products Administration (NMPA) for the first-line treatment for patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in combination with FOLFOX or FOLFIRI, or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy.

The pivotal Phase III evidence from the TAILOR study, on which the approval was based, shows significant benefit in overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) for patients treated with Erbitux in combination with FOLFOX, compared to FOLFOX alone, in the first-line setting for this challenging type of cancer.

“Erbitux, in combination with chemotherapy, has long been a standard of care for the treatment of RAS wild-type mCRC and the TAILOR study further demonstrates the possibilities it can bring in the first-line setting,” said Professor Jin Li, Tongji University Shanghai East Hospital, China and principal investigator in the TAILOR study, adding: “This approval marks an important development for patients in China, who now have the benefit of a new and much needed treatment option.”