Amgen's Vectibix Label Expanded - Analyst Blog

Amgen Inc. AMGN announced a label expansion for its oncology drug Vectibix in the U.S. Vectibix can now be used for the first-line treatment of patients suffering from wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC). The U.S. Food and Drug Administration (FDA) approved Vectibix in combination with an oxaliplatin-based chemotherapy regimen, Folfox.

Vectibix is the only biologic to provide a significant survival benefit in combination with Folfox for the first-line treatment of wild-type KRAS mCRC.

Simultaneously, the FDA approved Qiagen's QGEN therascreen (KRAS RGQ PCR Kit) as a companion diagnostic for Vectibix.

Vectibix was earlier approved as a monotherapy for the treatment of patients with EGFR-expressing mCRC after the disease had progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy. Amgen said that with the label expansion, the accelerated monotherapy approval has been converted to full approval.

In 2013, Vectibix revenues were $389 million, up 8%. Vectibix is gaining share in both the U.S. and Europe.

Meanwhile, Amgen is working towards strengthening its pipeline. We expect 2014 to be a catalyst rich year for Amgen as it gears up to present data on several late stage candidates.

The company intends to file for approval of evolocumab (cholesterol management) and ivabradine (chronic heart failure) in 2014. Kyprolis (approved in the U.S. for multiple myeloma) is being evaluated in several studies, including ASPIRE and FOCUS, with data from both expected in the second/third quarter of 2014.

Amgen carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD and Myriad Genetics Inc. MYGN. Both stocks carry a Zacks Rank #1 (Strong Buy).