Amgen’s colorectal cancer drug EU approved
pharmafile | April 8, 2015 | News story | Sales and Marketing | Amgen, Vectibix, ibrutinib, imbruvica, panitumumab, ristempa
The European Commission has shown Amgen’s cancer drug Vectibix the green light to treat patients in combination with chemotherapy for metastatic colorectal cancer, despite reports of bad side effects.
Vectibix (panitumumab) has been approved as first-line treatment to be used alongside an irinotecan-based chemotherapy regimen to treat the third most common cancer worldwide.
Whilst given the nod the treatment was shown to cause severe diarrhoea and dehydration, leading to acute renal failure and other complications during recent trials. The most common adverse reaction was a skin rash with further dermatologic toxicities occurring in 90% of patients, proving severe for around 15 per cent of those.
Moreover, fatal and non-fatal cases of interstitial lung disease and pulmonary fibrosis were also observed in patients treated with Vectibix.
Despite these severe side effects, Elliott Levy, who is the senior VP of global development at Amgen, insists: “The EC approval of Vectibix as a first-line treatment in combination with chemotherapy means physicians have another treatment option for adult patients with wild-type RAS metastatic colorectal cancer.”
Amgen’s Vectibix, which was recently added to NHS England’s revised CDF list along with Janssen’s leukaemia drug Imbruvica (ibrutinib), can also be used in second-line treatment in combination with chemotherapy plus as monotherapy (therapy taken alone) after failure of chemotherapy regimens.
Colorectal cancer is the second most common in Europe, with approximately 470,000 new cases reported each year. It is the second greatest cause of malignancy death second only to lung cancer, accounting for 12% of all cancer deaths.
Additionally Amgen will be hoping for further positive results from EU regulators when a final decision regarding its Ristempa (pegfilgrastim) for the treatment of neutropenia is made over the next three months.
The firm put forward an application to the European Medicines Agency in March for its drug to treat the condition characterised by an abnormally low level of neutrophils, a type of white blood cell.
Tom Robinson
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