Amgen appeals EMA CHMP negative opinion on Vectibix-chemotherapy combination for wild-type KRAS mCRC

Amgen (Nasdaq: AMGN) announced today that it has submitted a request to the European Medicines Agency (EMA) for a re-examination of the negative opinion issued in March by the Committee For Medicinal Products for Human Use (CHMP) for the use of Vectibix in combination with chemotherapy for patients with wild-type KRAS metastatic colorectal cancer (mCRC).

Amgen believes that Vectibix in combination with chemotherapy provides an important treatment option for patients with wild-type KRAS mCRC.  Amgen remains committed to patients with this aggressive disease, for whom there are limited treatment options.

Data from studies 20050203 (PRIME) and 20050181 ('181') showed that adding Vectibix to FOLFOX and FOLFIRI chemotherapy, respectively, improved progression-free survival (PFS) versus chemotherapy alone in patients with wild-type KRAS mCRC.  Patients taking this combination have a greater chance of living longer without their disease getting worse.  Additionally, the response rate of Vectibix plus chemotherapy was higher than chemotherapy alone.  Though quantitatively greater, the improvement in median overall survival did not achieve statistical significance in the Vectibix arm of either trial.

In general, adverse event rates were comparable across arms in both studies, with the exception of known toxicities associated with anti-EGFR therapy, such as rash, diarrhea, and hypomagnesemia. Vectibix-related grade 3/4 infusion reactions were reported in less than one percent of patients. In patients with mutant KRAS tumors, outcomes were inferior for those receiving Vectibix plus FOLFOX versus FOLFOX alone.

Vectibix is already approved and established in more than 30 countries outside of the United States (U.S.) as a monotherapy treatment for patients with wild-type KRAS mCRC, when standard chemotherapy is no longer effective. In the U.S., Vectibix received accelerated approval in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Furthermore, use of Vectibix is not recommended in patients whose tumors have KRAS mutations in codon 12 or 13. In Japan and Israel, Vectibix is also approved for use in combination with chemotherapy for patients with wild-type KRAS mCRC.