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Amgen's Colorectal Cancer Drug Gets FDA Nod to Expand Label

Amgen, Inc. AMGN announced that the FDA has approved a label expansion of its colorectal cancer drug, Vectibix.

Vectibix is now approved for use as first-line treatment of wild-type RAS metastatic colorectal cancer (mCRC) patients in combination with Folfox and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.

So far this year, Amgen’s shares are up 18%, better than the 11.6% increase registered by the Zacks classified Biomed/Genetics industry.

Wild-type RAS is defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use. Presently, Vectibix is approved as a treatment for patients with wild-type KRAS mCRC only. The approval of a refined indication of wild-type RAS mCRC was based on a retrospective analysis from the PRIME study and prospective, pre-defined analyses from the phase III ‘0007 study. Data from a key secondary endpoint of the ‘0007 study showed that patients with wild-type RAS (absence of mutations in exons 2, 3 and 4 of KRAS and NRAS) mCRC achieved median overall survival (OS) of 10 months when treated with Vectibix plus best supportive care (BSC) versus 6.9 months for BSC alone.

We believe the approval for an additional patient population can lead to improved sales of this cancer drug. The drug recorded sales of $147 million in the last reported quarter – first quarter of 2017 – representing growth of 2% year over year, driven by higher demand.

We remind investors that in 2015 Amgen re-acquired rights for Vectibix in select regions from GlaxoSmithKline GSK.

Amgen carries a Zacks Rank #3 (Hold).Better-ranked stocks in the sector include Regeneron Pharmaceuticals, Inc. REGN and VIVUS, Inc. VVUS, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings estimates have risen 3.4% for 2017 and 11% for 2018 over the last 60 days. Shares of the company have risen 38.9% so far this year.

VIVUS’ loss per share estimates narrowed 22% for 2017 in the last 60 days. The company delivered positive earnings surprises in all four trailing quarters with an average beat of 233.69%.  Shares of VIVUS have risen 5.3% this year so far.

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GlaxoSmithKline PLC (GSK): Free Stock Analysis Report
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VIVUS, Inc. (VVUS): Free Stock Analysis Report
Amgen Inc. (AMGN): Free Stock Analysis Report
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