As reported by Bloomberg, Seattle Genetics and its partner Takeda are expecting to apply for approval of their antibody drug conjugate, SGN-35, for the treatment of lymphoma when the latest clinical data is reported next week. SGN-35 will then be able to beat Roche's own ADC, known asT-DM1, to market (albeit for a different clinical application) and become the only ADC approved by the FDA at that point. A previous ADC, Mylotarg, was withdrawn from the market earlier this year by Pfizer. SGN-35 is expected to generate as much as $420 M annually by 2015 if approved.
Seattle Genetics, which has no marketed products, plans to apply to the U.S. Food and Drug Administration for conditional approval of SGN-35 in the first half of 2011, said Chairman and Chief Executive Officer Clay Siegall. That process would allow the drug to be used while the company conducts confirmatory studies. If the agency agrees, SGN-35 may be in doctors’ hands by the end of 2011, Siegall said in an interview.
The industry has been anxiously watching both SGN-35 and Roche's T-DM1 as these new class of drugs promise to make a large impact on the treatment of various cancers by allowing the targetted delivery of high-potent toxins to cancer cells. When these drugs are approved and prove themselves in the clinic, analysts expect a new wave of further therapies to follow using this strategy.
Seattle Genetics and other partners are also testing different antibody-drug combinations for treating cancers of the kidney, prostate, pancreas and other organs. The allies include Roche’s Genentech unit; Bayer AG of Leverkusen, Germany; Celldex Therapeutics Inc. of Needham, Massachusetts; Daiichi Sankyo Co. of Tokyo; GlaxoSmithKline Plc of London; AstraZeneca Plc of London, and Astellas Pharma Inc. of Tokyo.
Posted by Bruce Lehr December 4th 2010.