Amgen (AMGN) is appealing the negative recommendation issued by the Committee for Medicinal Products for Human Use (CHMP) for the use of Vectibix plus chemotherapy in patients with wild-type KRAS metastatic colorectal cancer (mCRC).

The company has requested the European Medicines Agency (EMA) to re-examine CHMP’s opinion.

Negative Opinion Issued in March 2011

The CHMP had adopted a negative opinion regarding Amgen’s marketing authorization application for Vectibix’s label expansion in March 2011. At that time, Amgen had said that it would appeal the opinion.

Results from two studies (PRIME and ‘181) showed that Vectibix plus chemotherapy improved progression-free survival in patients with wild-type KRAS mCRC compared to only chemotherapy. Moreover, Amgen reported a higher response rate in the Vectibix arm compared to chemotherapy alone.

Amgen is looking to drive Vectibix sales by expanding the label into second – and first-line treatment of metastatic colorectal cancer, which will expand the patient base significantly.

Vectibix is currently approved in several countries (excluding the US) as a monotherapy treatment for wild-type KRAS mCRC patients who are no longer responding to standard chemotherapy. Meanwhile, Vectibix is approved in the US as a monotherapy treatment for patients with EGFR-expressing mCRC after the disease has progressed following or while on treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

The colorectal cancer market represents huge potential. According to estimates provided by the company in its press release, about 1.23 million cases of colorectal cancer were diagnosed across the world in 2008. In the EU alone, about 333,330 new cases of colorectal cancer were diagnosed in 2008.

Amgen is currently seeking US approval for the use of Vectibix for first- and second-line mCRC. Vectibix’ primary competitor is Eli Lilly/Bristol-MyersSquibbs’ (LLY/BMY) Erbitux.

We currently have a Neutral recommendation on Amgen. We expect investor focus to remain on the successful commercialization of Prolia/Xgeva.

 
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