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Seattle Genetics, Inc. Message Board

  • nhanduyvo nhanduyvo Feb 15, 2013 12:19 AM Flag

    SGEN request for "Breakthrought" Designation

    I wonder if SGEN makes any requests to FDA for any "Breakthrough" designation for different drugs in its pipeline.

    You may hear "breakthrough" designation in the coming days!

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    • My guess is that they have already applied. They have enough excellent data in several indications to justify breakthrough designation.
      FDA has given Adcetris very favorable treatment so far and Adcetris is just the sort of drug breakthrough was designed to advance. I would expect a label expansion quickly.
      No other solely own drug in the pipeline presides Adcetris is advanced enough to qualify.

    • I'm not familiar with "breakthrough" designation. Please give brief description. Does it shorten the Phase I, II, III requirements.

      Sentiment: Strong Buy

      • 1 Reply to biogynecologist
      • Here it is:
        One of the most tantalizing new programs now being rolled out at the FDA is its brand new category for "breakthrough" drugs, offering a select number of companies a chance at a shortcut to the market based on early-stage data for transformational new therapies. So when Janet Woodcock, the influential director of the FDA's Center for Drug Evaluation and Research, started outlining how the program will work--indicating that a company can move from an expanded Phase I directly to commercialization, Bloomberg reporters were paying close attention.

        According to the business news wire, Woodcock says that companies which earn breakthrough status will have the ear of the agency. "We expect many of these would come available very quickly with Phase I data," she said.

        So far, we know that Vertex ($VRTX) has won breakthrough status for two drugs for cystic fibrosis, the approved drug Kalydeco and the experimental VX-809, now being studied as a combination therapy. According to Woodcock, a third drug has been anointed with the special status. And developers have submitted 18 for review, most of which are for cancer.

    • Breakthrough as it may apply to CLDX:
      You seemed to only scratch the surface but did so well on the lead programs.If I might recommend if you do #$%$ article look into the pipeline and relate that to the recent speech given by Janet Woodcock at FDA on "Breakthrough Drugs" (attached)...its my guess that CLDX has several that FIT the BILL"
      Of course SGEN will receive milestone payments and royalties from CLDX.
      Roche also as 2 B-cell candidates which may qualify.
      Breakthrough will be a game changer.

    • You dont apply the FDA has its own parameters

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