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Amgen gets EU nod for wider use of Vectibix

US biotech’s cancer therapy can now be used in a first-line setting

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Amgen's Vectibix has been cleared in the EU for use with another chemotherapy regimen commonly used to treat patients with metastatic colorectal cancer (mCRC).

Vectibix (panitumumab) can now be used as a first-line treatment for patients with wild-type RAS metastatic colorectal cancer alongside FOLFIRI chemotherapy (consisting of irinotecan, fluorouracil and folinic acid), one of the most widely-used regimens for first-line CRC in Europe.

In 2011, Amgen's drug was approved in the EU as a first-line therapy for wild-type RAS mCRC in combination with another regimen called FOLFOX (oxaliplatin, fluorouracil and folinic acid), adding to its earlier approvals as a second-line monotherapy in patients who had progressed despite earlier chemotherapy.

Europe has the highest incidence of CRC in the world, with around 470,000 new cases each year, making it the second most common cancer in the region after lung cancer. About half of all mCRC patients are classified as wild-type RAS.

Epidermal growth factor receptor (EGFR) inhibitor Vectibix has been steadily gaining ground as a first-line CRC therapy and grew 29% last year to reach $505m after securing first-line use in mCRC alongside FOLFOX in the US.

Last year, two trials comparing Vectibix with Roche's vascular endothelial growth factor (VEGF) blocker Avastin (bevacizumab) - another commonly used biologic therapy for CRC - on top of FOLFOX showed an improvement for Amgen's drug in overall survival although the two therapies were equally effective on the primary endpoint of progression-free survival (PFS).

Moreover, the studies also revealed differences in the response of patients to Vectibix therapy depending on their RAS mutations - for example if they had mutations in KRAS and NRAS exons 2, 3, and 4 - which could have had an impact on the PFS finding.

The drug is a recent addition to England's Cancer Drugs Fund, which saw a raft of other therapies de-listed earlier this year.

Article by
Phil Taylor

7th April 2015

From: Sales



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