Amgen (Nasdaq: AMGN) today issued the following statement:
Amgen has received notice that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion for Amgen's application to extend the marketing authorization in Europe for Vectibix® (panitumumab) to include combination with chemotherapy for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC).
Amgen will review the CHMP opinion and consider appropriate next steps, as 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.
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 approved for use in combination with chemotherapy for patients with wild-type KRAS mCRC.
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. Although numerically greater, the improvement in median overall survival (OS) did not achieve statistical significance in the Vectibix arm of either trial.
In general, adverse events 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 mutated KRAS tumors, outcomes were inferior for those receiving Vectibix plus FOLFOX versus FOLFOX alone.