Takeda, Seattle Genetics (SGEN) Applys for ADCETRIS MAA in Europe

Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited and Seattle Genetics, Inc. (Nasdaq: SGEN), today reported data from a retrospective analysis of pediatric patients (12 – 17 yrs) enrolled in four multicenter clinical trials (two phase I and two phase II) of ADCETRIS. All patients were diagnosed with relapsed or refractory Hodgkin lymphoma (HL) (n=5) or systemic anaplastic large cell lymphoma (sALCL) (n=4) and had failed at least one prior chemotherapy regimen. The data were reported today during an oral presentation at the 2011 European Multidisciplinary Cancer Congress being held September 23 – 27, in Stockholm, Sweden.

The marketing authorization application for ADCETRIS in relapsed or refractory HL and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted by the European Medicines Agency in June 2011. ADCETRIS was granted accelerated approval by the U.S. Food and Drug Administration in August 2011 for two indications: (1) 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 ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. These indications are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS. ADCETRIS has not been approved for the treatment of pediatric patients.

Clinical response was assessed by the investigator using the Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

• Six of nine patients achieved a complete remission (CR) after treatment with ADCETRIS, including all four sALCL patients, and the remaining three patients achieved stable disease (SD)
  
  
• Five of the 6 patients with CR remained in remission after follow-up that ranged from 3 to more than 15 months
  
  
• ADCETRIS was associated with generally manageable adverse events; the most common, determined as treatment-emergent events occurring in more than 4 patients, were nausea (n=6), peripheral neuropathy (n=6), fatigue (n=5), cough (n=4), mouth and throat pain (n=4), and fever (n=4)
  
  
• Adverse events of Grade 3 or higher were neutropenia (n=3), decrease in white blood cell count (n=1), thrombocytopenia (n=1), catheter site infection (n=1), and hyperesthesia (n=1)

---

Serious News for Serious Traders! Try StreetInsider.com Premium Free!

---

You May Also Be Interested In

• Getty Realty discloses separation terms for departing accounting officer
• Real and RE/MAX Holdings set Aug. 24 merger closing date
• Blue Moon Metals cleared to build at Nevada tungsten project