T-Cell Lymphomas

Astex Pharmaceuticals Announces That Tolinapant (ASTX660), a Novel Antagonist of Cellular and X-linked Inhibitors of Apoptosis Proteins, Has Been Granted Orphan Drug Designation for the Treatment of T-cell Lymphomas by the US FDA

Retrieved on: 
Monday, August 31, 2020

Orphan drug designation is granted to drugs intended to treat a rare disease or condition.

Key Points: 
  • Orphan drug designation is granted to drugs intended to treat a rare disease or condition.
  • The designation provides for seven years of marketing exclusivity in the US following product approval, as well as certain tax incentives and grants.
  • Astexs development of tolinapant is aimed at bringing a new therapeutic option for patients with this type of cancer.
  • Tolinapant is a novel, orally administered, non-peptidomimetic antagonist of the cellular and X-linked inhibitors of apoptosis proteins (cIAP1/2 and XIAP).

Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Receives European Commission Approval for Treatment of Adult Patients with Previously Untreated Systemic Anaplastic Large Cell Lymphoma

Retrieved on: 
Thursday, May 14, 2020

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that its collaborator, Takeda Pharmaceutical Company Limited, received approval from the European Commission to extend the current conditional marketing authorization for ADCETRIS (brentuximab vedotin) to include treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with CHP (cyclophosphamide, doxorubicin, prednisone).

Key Points: 
  • Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that its collaborator, Takeda Pharmaceutical Company Limited, received approval from the European Commission to extend the current conditional marketing authorization for ADCETRIS (brentuximab vedotin) to include treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with CHP (cyclophosphamide, doxorubicin, prednisone).
  • For further details about the European Commission decision, please visit the European Medicines Agency website: www.ema.europa.eu/ema .
  • These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.
  • Administer G-CSF primary prophylaxis beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL.

Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS® (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials at the 2019 ASH Annual Meeting

Retrieved on: 
Monday, December 9, 2019

Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced additional analyses of results from the ECHELON-1 and ECHELON-2 frontline phase 3 trials of ADCETRIS (brentuximab vedotin).

Key Points: 
  • Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced additional analyses of results from the ECHELON-1 and ECHELON-2 frontline phase 3 trials of ADCETRIS (brentuximab vedotin).
  • In addition, the overall survival benefit in the ADCETRIS plus CHP arm was statistically significant compared to CHOP (HR, 0.66; p=0.0244).
  • ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas.
  • Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS® (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials at the 2019 ASH Annual Meeting

Retrieved on: 
Monday, December 9, 2019

Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced additional analyses of results from the ECHELON-1 and ECHELON-2 frontline phase 3 trials of ADCETRIS (brentuximab vedotin).

Key Points: 
  • Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced additional analyses of results from the ECHELON-1 and ECHELON-2 frontline phase 3 trials of ADCETRIS (brentuximab vedotin).
  • In addition, the overall survival benefit in the ADCETRIS plus CHP arm was statistically significant compared to CHOP (HR, 0.66; p=0.0244).
  • ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas.
  • Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

Seattle Genetics Announces Health Canada Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy in Frontline CD30-Expressing Peripheral T-Cell Lymphoma

Retrieved on: 
Monday, November 25, 2019

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL.

Key Points: 
  • ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL.
  • These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.
  • ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology.
  • ADCETRIS has received marketing authorization by regulatory authorities in 73 countries for relapsed or refractory Hodgkin lymphoma and sALCL.