We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Amgen's Colorectal Cancer Drug Gets FDA Nod to Expand Label
Read MoreHide Full Article
Amgen, Inc. (AMGN - Free Report) 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 - Free Report) .
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.
5 Trades Could Profit ""Big-League"" from Trump Policies
If the stocks above spark your interest, wait until you look into companies primed to make substantial gains from Washington's changing course.
Today Zacks reveals 5 tickers that could benefit from new trends like streamlined drug approvals, tariffs, lower taxes, higher interest rates, and spending surges in defense and infrastructure. See these buy recommendations now >>
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Amgen's Colorectal Cancer Drug Gets FDA Nod to Expand Label
Amgen, Inc. (AMGN - Free Report) 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 - Free Report) .
Amgen carries a Zacks Rank #3 (Hold).Better-ranked stocks in the sector include Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and VIVUS, Inc. , 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.
5 Trades Could Profit ""Big-League"" from Trump Policies
If the stocks above spark your interest, wait until you look into companies primed to make substantial gains from Washington's changing course.
Today Zacks reveals 5 tickers that could benefit from new trends like streamlined drug approvals, tariffs, lower taxes, higher interest rates, and spending surges in defense and infrastructure. See these buy recommendations now >>