This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Seattle Genetics Cancer Drug Passes Test

BOTHELL, Wash. ( TheStreet) -- Seattle Genetics (SGEN - Get Report) announced Monday results from a pivotal study demonstrating that 75% of patients with advanced Hodgkin lymphoma responded for greater than six months to treatment with the experimental drug brentuximab vedotin.

The positive results from the study are strong enough to allow Seattle Genetics to seek U.S. regulatory approval for brentuximab in the first half of next year, the company said.

Seattle Genetics shares closed Friday at $12.16.

Brentuximab, also known as SGN-35, is designed using a technology proprietary to Seattle Genetics that delivers a lethal dose of chemotherapy directly to cancer cells while sparing healthy cells from toxic effects. Brentuximab consists of an antibody that attaches itself to a certain receptor found on tumor cells. Once inside the tumor, brentuximab releases a toxic chemotherapy payload.

The pivotal phase study was designed under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration. Just over 100 patients with Hodgkin lymphoma were enrolled in the study, all of whom had disease that was no longer responsive to currently approved therapies, including autologous stem cell transplants.

After treatment with brentuximab, 75% of the patients demonstrated either a complete or partial response. The duration of response was greater than six months. The drug's safety profile was "consistent" with previous studies, Seattle Genetics said. Additional details from the study are being withheld so they can be presented at a future medical meeting.

"Few drugs ever demonstrate this level of response in the refractory setting, " said Seattle Genetics CEO Clay Siegall, in an interview Sunday. " We believe brentuximab provides a real opportunity and hope for Hodgkin patients in this setting for which there has been no major advance in years."

The FDA did not specify a brentuximab response rate necessary for the drug to be approved as a new treatment for Hodgkin lymphoma, but Seattle Genetics said previously that a 25-30% response rate lasting at least six months would be considered robust.

A previous, smaller study of brentuximab yielded response rates in the range of 50-60%.

About 8,500 patients in the U.S. each year are diagnosed with Hodgkin lymphoma, a cancer that affects white blood cells. Most of these patients are treated successfully with a four-drug chemotherapy cocktail or stem-cell transplants. Seattle Genetics intends to seek approval for brentuximab initially in the approximately 30% of patients who do not respond to current therapies or relapse.
1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
SGEN $36.37 2.51%
AAPL $93.64 -0.11%
FB $118.57 0.84%
GOOG $698.21 0.75%
TSLA $241.80 0.43%


Chart of I:DJI
DOW 17,891.16 +117.52 0.66%
S&P 500 2,081.43 +16.13 0.78%
NASDAQ 4,817.5940 +42.2360 0.88%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs