Lymphoma (includes NHL, HL, CNS Lymphoma)

FDA Accepts Supplemental Biologics License Application and Grants Priority Review for ADCETRIS® (Brentuximab Vedotin) in Cutaneous T-Cell Lymphoma

(Yahoo! Finance) Aug 16, 2017 - Seattle Genetics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase 3 ALCANZA trial and two phase 2 investigator-sponsored trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL).

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FDA Accepts Supplemental Biologics License Application and Grants Priority Review for ADCETRIS® (Brentuximab Vedotin) in Cutaneous T-Cell Lymphoma

(Seattle Genetics) Aug 16, 2017 - Seattle Genetics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase 3 ALCANZA trial and two phase 2 investigator-sponsored trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL).

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Institute for Clinical and Economic Review Posts Draft Scoping Document on CAR-T Therapies for Public Comment

(ICER) Aug 9, 2017 - The Institute for Clinical and Economic Review (ICER) has posted a Draft Scoping Document on chimeric antigen receptor t-cell (CAR-T) therapies for treatment of B-cell malignancies. The document will be open to public comment for three weeks until August 29, 2017 at 5pm ET.

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TG Therapeutics, Inc. Announces Successful Outcome from the First Pre-Planned Interim Analysis by Independent DSMB of the DLBCL Cohort in the UNITY-NHL Phase 2b Trial

(Morningstar) Aug 10, 2017 - TG Therapeutics, Inc., today announced that the independent Data Safety Monitoring Board (DSMB) of the UNITY-NHL Phase 2b registration directed trial has successfully completed the first pre-specified interim analysis to evaluate the Overall Response Rate (ORR) in the cohort enrolling patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) that are not eligible for high-dose chemotherapy or transplant.

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Prepping For A Rapid-Fire Launch, Kite Pharma Gets A Pass From FDA On Axi-Cel Panel Review

(Endpoints News) Aug 8, 2017 - The FDA has evidently learned all it wants at this point from its outside oncology experts on CAR-T. Kite Pharma’s closely-watched CAR-T drug axi-cel is getting a pass on an adcomm meeting, which may signal a quick thumbs up from regulators.

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Kite Begins EU Trial of CAR–T Therapy

(PharmaTimes [UK]) Aug 7, 2017 - Kite Pharma has begun treating the first EU patients with its investigational CAR–T candidate, axicabtagene ciloleucel (axi-cel), in the safety expansion cohort of the ZUMA-1 trial.

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Skip the Bone Marrow Biopsy in Follicular Lymphoma?

(Medscape Medical News) Aug 2, 2017 - Clinical trials in patients with follicular lymphoma (FL) mandate that patients undergo bone marrow biopsies (BMBs) at baseline and at subsequent points following treatment in order to monitor response.

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FDA Approves Treatment For Chronic Graft Versus Host Disease

(FDA.gov) Aug 2, 2017 - The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.

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US Oncology Research and Epizyme Establish Collaboration to Identify Non-Hodgkin Lymphoma Patients with EZH2 Mutations

(The US Oncology Network) Aug 1, 2017 - Eligible patients to be directed to Epizyme’s ongoing phase 2 clinical trial of tazemetostat in follicular lymphoma and diffuse large B-cell lymphoma.

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Kite Doses First Patient in the Phase 2 Trial of Axicabtagene Ciloleucel in Indolent B-Cell Non-Hodgkin Lymphoma (ZUMA-5)

(Kite) Aug 2, 2017 - Kite Pharma, Inc. today announced that patients with relapsed/refractory indolent B-cell non-Hodgkin lymphoma (iNHL) are now being treated in its Phase 2 ZUMA-5 trial with its lead investigational candidate, axicabtagene ciloleucel (axi-cel).

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Acalabrutinib Granted Breakthrough Therapy Designation By US FDA For The Treatment Of Patients With Mantle Cell Lymphoma

(AstraZeneca) Aug 1, 2017 - AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is a highly-selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers.

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AstraZeneca Gets Breakthrough Status For Blood Cancer Drug

(Reuters) Aug 1, 2017 - AstraZeneca said on Tuesday that U.S. regulators had awarded its blood cancer drug acalabrutinib "breakthrough" status for the treatment of patients with mantle cell lymphoma, a rare type of blood cancer.

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Rituximab Biosimilars Shown to Be Safe and Effective

(Medscape Medical News) July 28, 2017 - Clinical trial data showing that two biosimilar rituximab products are comparable to the reference product, Rituxan (Genentech) (in Europe, MabThera), were published online July 13 in the Lancet Hematology.

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Kite Files the Industry's First CAR-T Marketing Authorization Application in Europe for Axicabtagene Ciloleucel

(TheStreet) July 31, 2017 - Kite Pharma, Inc., a leading cell therapy company, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are ineligible for autologous stem cell transplant.

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NICE Approval For Nivolumab Provides New Treatment For Advanced Blood Cancer

(NICE) July 26, 2017 - Nivolumab, also known as Opdivo, will be routinely available for patients with classical Hodgkin lymphoma who have exhausted all other treatments.

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Loxo Oncology Announces Acquisition of Highly Selective, Reversible BTK Inhibitor Program

(NASDAQ) July 31, 2017 - Loxo Oncology, Inc., a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the company has entered into a definitive agreement to purchase the Bruton's tyrosine kinase (BTK) inhibitor program from Redx Pharma Plc. The lead candidate from this program is expected to enter clinical development in 2018.

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NICE Backs Roche’s Gazyvaro For Follicular Lymphoma

(PharmaTimes [UK]) July 26, 2017 - The National Institute for Health and Care Excellence has issued final draft guidance recommending that use of Roche’s Gazyvaro to treat follicular lymphoma be funded for NHS use via the Cancer Drug Fund.

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Health Canada Approves ADCETRIS® (Brentuximab Vedotin) For The Post-ASCT Consolidation Treatment Of Patients With Hodgkin Lymphoma At Increased Risk Of Relapse Or Progression

(The Street) July 25, 2017 - Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that Health Canada has issued a non-conditional marketing authorization for use of ADCETRIS as post-autologous stem cell transplant (ASCT) consolidation treatment of patients with Hodgkin lymphoma (HL) at increased risk of relapse or progression.

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New 3-year Data Supports Kite ‘Cure’ Hopes For CAR-T

(Pharmaphorum [UK]) July 21, 2017 - A handful of patients with aggressive leukaemia appeared to have been cured thanks to CAR-T therapy, with some living more than four years with complete remission (CR).

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Growing a Baby After a Tumor

(New York Times/Well blog) July 20, 2017 - To me, this growth, this mass, was indistinguishable from the last one. Was it trying to kill me?

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