Diffuse large B-cell lymphoma

DGAP-News: FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Saturday, August 1, 2020 - 1:00am

The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

Key Points: 
  • The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.
  • "The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States," said Herv Hoppenot, Chief Executive Officer, Incyte.
  • "Today's FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy."
  • The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL.

FDA Approves Monjuvi® (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Saturday, August 1, 2020 - 12:51am

The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

Key Points: 
  • The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.
  • The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States, said Herv Hoppenot, Chief Executive Officer, Incyte.
  • The FDA approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter, single arm trial of Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL.
  • The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL.

U.S. Food and Drug Administration Accepts Karyopharm’s Supplemental New Drug Application for XPOVIO® (selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Line of Therapy

Monday, July 20, 2020 - 12:00pm

If approved, we believe XPOVIO will become an important new, oral, once-weekly treatment option, used in combination with once-weekly Velcade, for patients with multiple myeloma after at least one prior line of therapy.

Key Points: 
  • If approved, we believe XPOVIO will become an important new, oral, once-weekly treatment option, used in combination with once-weekly Velcade, for patients with multiple myeloma after at least one prior line of therapy.
  • XPOVIO has been previously approved by the FDA for the treatment of patients with penta-refractory multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma.
  • Karyopharms supplemental New Drug Application (sNDA) requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy has been accepted for filing by the FDA.
  • Thrombocytopenia was reported in patients with multiple myeloma (MM) and developed or worsened in patients with DLBCL.

ADC Therapeutics Announces First Patient Dosed in Pivotal Phase 2 Portion of LOTIS 3 Clinical Trial of Loncastuximab Tesirine (Lonca) in Combination With Ibrutinib

Friday, July 17, 2020 - 12:15pm

We are pleased to have dosed the first patient in the pivotal Phase 2 portion of this trial as we continue advancing Lonca as both a single agent and in combination with other therapies for patients with non-Hodgkin lymphoma.

Key Points: 
  • We are pleased to have dosed the first patient in the pivotal Phase 2 portion of this trial as we continue advancing Lonca as both a single agent and in combination with other therapies for patients with non-Hodgkin lymphoma.
  • The 161-patient Phase 1/2 open-label, single-arm clinical trial is evaluating the safety and efficacy of Lonca in combination with ibrutinib in patients with relapsed or refractory DLBCL or MCL.
  • The Phase 2 portion of the trial will enroll three cohorts: non-germinal center B-cell-like (non-GCB) DLBCL, GCB DLBCL and MCL.
  • ADC Therapeutics is based in Lausanne (Biople), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey.

XPOVIO® (selinexor) Now Approved for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Available from Onco360

Wednesday, June 24, 2020 - 7:00pm

Onco360 is excited to be selected as a specialty pharmacy provider for XPOVIO patients, said Paul Jardina, President and CEO, Onco360.

Key Points: 
  • Onco360 is excited to be selected as a specialty pharmacy provider for XPOVIO patients, said Paul Jardina, President and CEO, Onco360.
  • The recent approval of XPOVIO unlocks a new treatment option for relapsed or refractory DLBCL patients who have failed previous lines of treatment.
  • As a provider of this key treatment, Onco360 can support the highly specialized needs of relapsed or refractory DLBCL patients and their physicians across the states.
  • Onco360 is the largest independent Oncology Pharmacy and clinical support services company in the country.

Veracyte Announces De Novo Classification Request to FDA for the nCounter Dx LymphMark Assay

Tuesday, June 9, 2020 - 1:15pm

(Nasdaq: VCYT) today announced its submission of a De Novo classification request to the U.S. Food & Drug Administration (FDA) for the nCounter Dx LymphMark Assay, a novel, genomic lymphoma subtyping test.

Key Points: 
  • (Nasdaq: VCYT) today announced its submission of a De Novo classification request to the U.S. Food & Drug Administration (FDA) for the nCounter Dx LymphMark Assay, a novel, genomic lymphoma subtyping test.
  • The LymphMark test utilizes gene-expression profiling of RNA extracted from formalin-fixed paraffin-embedded tissue to classify the cell of origin subtype of DLBCL tumors.
  • Veracyte acquired the LymphMark test in December 2019 as part of its acquisition from NanoString of the exclusive global diagnostic rights to the nCounter system.
  • Veracyte, Afirma, Percepta, Envisia, Prosigna, LymphMark, nCounter and the Veracyte logo are trademarks of Veracyte, Inc.
    1 Swerdlow SH, Campo E, Pileri SA, et al.

DGAP-News: MorphoSys to Present at Upcoming Virtual Investor Conferences

Tuesday, June 2, 2020 - 10:07pm

In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval.

Key Points: 
  • In 2017, Tremfya(R), marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval.
  • MorphoSys most advanced proprietary product candidate, tafasitamab (MOR208), is in late-stage clinical development for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL).
  • Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees.
  • More information at www.morphosys.com
    HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R), arYla(R), Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R), LanthioPep(R) and ENFORCER(R) are trademarks of the MorphoSys Group.

Autolus Therapeutics Presents Encouraging Additional Data Showcasing Clinical Progress of Programmed T Cell Therapy Pipeline in Blood Cancers

Thursday, January 30, 2020 - 12:00pm

LONDON, Jan. 30, 2020 (GLOBE NEWSWIRE) -- Autolus Therapeuticsplc(Nasdaq: AUTL) today announced additional data regarding its ongoing Phase 1/2 clinical trial of its next-generation programmed T cell therapy, AUTO3, to treat adults with relapsed/refractory diffuse large B cell lymphoma (DLBCL).

Key Points: 
  • LONDON, Jan. 30, 2020 (GLOBE NEWSWIRE) -- Autolus Therapeuticsplc(Nasdaq: AUTL) today announced additional data regarding its ongoing Phase 1/2 clinical trial of its next-generation programmed T cell therapy, AUTO3, to treat adults with relapsed/refractory diffuse large B cell lymphoma (DLBCL).
  • The data is to be presented in a keynote lecture titled Improved CAR T cell approaches for lymphoid malignancies, by Dr. Martin Pul, clinical senior lecturer in the Dept.
  • Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer.
  • AUTO3 is currently being tested in adult diffuse large B cell lymphoma in the ALEXANDER clinical trial and in pediatric ALL in the AMELIA clinical trial.

HTG Molecular Diagnostics Receives European Patent Grant Notification for Methods for Subtyping Diffuse Large B-cell Lymphoma

Tuesday, January 28, 2020 - 1:00pm

TUCSON, Ariz., Jan. 28, 2020 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics , Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced it has received notification of validation of European patent number EP 3356554 for its methods for subtyping diffuse large B-cell lymphoma (DLBCL), effective October 2019.

Key Points: 
  • TUCSON, Ariz., Jan. 28, 2020 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics , Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today announced it has received notification of validation of European patent number EP 3356554 for its methods for subtyping diffuse large B-cell lymphoma (DLBCL), effective October 2019.
  • HTG was previously granted a patent for this technology in the United States in 2018.
  • Lymphoma is the most common blood cancer, and DLBCL is the most common form of nonHodgkins lymphoma, accounting for up to 30 percent of newly diagnosed cases.
  • We believe molecular subtyping may be used to better predict the prognosis and/or treatment of lymphoma patients who might benefit from such personalized medicine.

ADC Therapeutics Announces Oral Presentation of Interim Efficacy Data from Pivotal Phase 2 Clinical Trial of ADCT-402 (Loncastuximab Tesirine) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma at 61st ASH Annual Meeting

Monday, December 9, 2019 - 7:45pm

The data continue to reinforce the significant single-agent, anti-tumor activity and manageable toxicity profile of ADCT-402 in patients with relapsed or refractory DLBCL, even in difficult-to-treat patients.

Key Points: 
  • The data continue to reinforce the significant single-agent, anti-tumor activity and manageable toxicity profile of ADCT-402 in patients with relapsed or refractory DLBCL, even in difficult-to-treat patients.
  • DLBCL is a common and aggressive cancer that can be challenging to treat due to its frequent resistance to available treatments.
  • Patients who have failed established therapies are limited in their treatment options, creating a critical need for a new therapy.
  • ADC Therapeutics is based in Lausanne (Biople), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey.