Amgen, a pharmaceutical company devoted to the development of novel human therapeutics for serious diseases, recently announced that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued their approval for combination of Amgens’ innovative drug Vectibix (panitumumab), with FOLFIRI chemotherapy (a irinotecan-based chemotherapy) as a first-line treatment to adult patients with metastatic colorectal cancer (mCRC), specifically, wild-type RAS mCRC patients.
This type of colorectal cancer does not present mutations in the KRAS gene, an important player in colorectal cancer. As such, drug efficacy could be enhanced as KRAS mutation is predictive of a very poor response to Vectibix (panitumumab) in CRC patients.
The Committee reviewed data from the 20060314 study to make their decision – a study where researchers evaluated the combination of Vectibix with FOLFIRI chemotherapy in mCRC patients.
The CHMP supporting statement will now be evaluated by the European Commission, which will decide whether to support the Committee’s decision to extend a marketing authorization of Vectibix with FOLFIRI as first line-treatment for mCRC.
Of note, Vectibix is approved in Europe for the treatment of adult patients with wild-type RAS mCRC in the following regiments:
– as a first-line treatment in combination with FOLFOX (a chemotherapy regimen for patients with CRC composed of Folinic acid (leucovorin), Fluorouracil (5-FU) and Oxaliplatin (Eloxatin));
– as second-line treatment in combination with FOLFIRI (this treatment is submitted after patients had a first-line treatment with fluoropyrimidine-based chemotherapy);
– as monotherapy in the case of failure with other chemotherapy regiments
With the exception of skin cancers, CRC is the third most common cancer in both men and women with estimates of 1.2 million cases worldwide. In the United States alone, the American Cancer Society estimates that during 2015 a total of 93,090 new cases of colon cancer and 39,610 new cases of rectal cancer will be diagnosed.
Elliott M. Levy, M.D., senior vice president of Global Development at Amgen noted in a press release “Adding Vectibix to chemotherapy as first-line treatment in patients with wild-type RAS metastatic colorectal cancer has been shown to result in better responses than chemotherapy alone. The CHMP recommendation is an important step toward increasing the treatment options for patients with this aggressive disease and helping improve outcomes in the European Union.”