Amgen (AMGN) recently announced that it received approval from the European Commission (EC) for a label expansion of its colorectal cancer product, Vectibix. Amgen gained EU approval for the use of Vectibix as a first-line treatment in combination with FOLFOX and second-line treatment in combination with FOLFIRI in patients with wild-type KRAS metastatic colorectal cancer (mCRC) who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
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. Results from two studies (PRIME and ‘181) showed that Vectibix plus chemotherapy (FOLFOX or FOLFIRI) 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 plus chemotherapy arm compared to chemotherapy alone.
Vectibix is currently approved in several countries 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 a huge potential. According to estimates provided by the company in its press release, about 1.2 million cases of colorectal cancer are expected to occur worldwide. Players in the colorectal cancer market include Eli Lilly/Bristol-Myers Squibbs' (LLY/BMY) Erbitux.
Neutral on Amgen
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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