Back to top

Analyst Blog

Seattle Genetics, Inc. (SGEN - Snapshot Report) recently announced that the US Food and Drug Administration (FDA) has accepted its supplemental biologics license application (sBLA) seeking approval of Adcetris (brentuximab vedotin) for an additional indication. The company is looking to get Adcetris approved for retreatment and extended duration of medication with the drug beyond 16 cycles in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).

We remind investors that Seattle Genetics submitted the sBLA to the FDA in Mar 2013 on the basis of encouraging data from a phase II study. The study had two treatment arms. One arm evaluated retreatment with Adcetris in patients who had responded to Adcetris treatment earlier, then discontinued treatment and as a result suffered disease progression or relapse. The other arm evaluated prolonged treatment with Adcetris beyond 16 cycles of medication. 70% of patients retreated with Adcetris and 88% of patients with extended treatment with Adcetris achieved an objective response. In both the settings, Adcetris was well tolerated. A final decision from the FDA is expected by Sep 14, 2013 (action date).

We note that Adcetris was approved by the FDA in Aug 2011 for the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not suitable for ASCT. Adcetris was also approved for sALCL in treatment-experienced patients.

We are positive on Seattle Genetics’ efforts to expand Adcetris’ label. Successful label expansion should boost the sales potential of the drug. Adcetris’ net product revenue in the first quarter of 2013 was $33.9 million. Adcetris is also being evaluated in other indications.

Seattle Genetics carries a Zacks Rank #2 (Buy). Right now, Alkermes plc (ALKS - Analyst Report) and Anika Therapeutics Inc. look more attractive with a Zacks Rank #1 (Strong Buy). Myriad Genetics Inc. (MYGN - Analyst Report) also carries Zacks Rank #2.

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
RPC INC RES 24.91 +8.35%
LITHIA MOTO… LAD 94.59 +4.60%
DELTA AIR L… DAL 39.15 +3.90%
FLAMEL TECH… FLML 14.51 +3.50%
SOUTHWEST A… LUV 28.87 +2.92%