The company has received FDA approvals for two cancer drugs in less than 12 months and announced partnerships with Merck last month for a Phase II antibody-drug conjugate and a marketed drug.
One deal is a $4.2 billion development and commercialization partnership focused on ladiratuzumab vedotin, while the other would expand the reach of the breast cancer drug Tukysa.
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The company is seeking approval for tucatinib, combined with two other drugs, for patients with HER2-positive breast cancer who have had at least three prior HER2-targeting therapies.
The drug, Enhertu, is the subject of an ongoing legal dispute between Daiichi Sankyo and Seattle Genetics, which alleges that the Tokyo-based drugmaker used its technology. The two had a partnership from 2008-2015.
The FDA approved Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate for locally advanced or metastatic urothelial carcinoma, which marks the Seattle biotech's second regulatory approval.
Seattle Genetics alleges that the Japanese drugmaker's DS-8201 uses a linker and other technology that improve on the U.S. company's own technology. The drug is also the subject of a $7 billion partnership with AstraZeneca.
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Topline data from the Phase II study of tucatinib showed the drug combined with an antibody-chemotherapy combination improved progression-free survival over the doublet by itself. Seattle Genetics acquired the drug when it bought Cascadian for $614 million last year.
The drug, Polivy, was developed using antibody-drug conjugate technology in-licensed from Seattle Genetics. It received accelerated approval Monday for diffuse large B-cell patients relapsed or refractory after at least two prior therapies.
Adcetris made by Seattle Genetics for classical stage III or stage IV Hodgkin lymphoma has received FDA approval for use in combination with chemotherapy for previously untreated disease.
Activist investor venBio had a good Friday. Seattle Genetics and Immunomedics did not. The two latter companies agreed to fold on their $2 billion oncology deal, while Immunomedics' CEO and CSO also forfeited their jobs.
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Seattle Genetics has secured global rights to Immunomedics' antibody-drug conjugate IMMU-132 (sacituzumab govitecan), currently in late-stage trials for triple-negative metastatic breast cancer. If the drug succeeds, the deal could be worth up to $2 billion.
Three out of five clinical trials evaluating Seattle Genetics' investigational ADC vadastuximab have ground to a halt after six adverse events and four fatalities were reported. No such toxicity has been reported in trials involving newly-diagnosed patients.
At the headquarters of Public Health — Seattle & King County in downtown Seattle, those leading the county’s effort to get people to sign up for insurance under the new federal health-care law are conspiring around a table. Chris B...
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