Lymphoma (includes NHL, HL, CNS Lymphoma)

AbbVie to Highlight Breadth of Innovative Science and Ongoing Commitment to Blood Cancer Patients with New Data From Studies of Ibrutinib and Venetoclax at 2018 American Society of Hematology Annual Meeting & Exposition

(Yahoo! Finance) Nov 20, 2018 - Results will be presented from the Phase 3 iLLUMINATE trial evaluating the safety and efficacy of ibrutinib (Imbruvica®) in combination with obinutuzumab vs. chlorambucil in combination with obinutuzumab in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received a prior treatment.

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FDA Approves First-Line Treatment For Peripheral T-Cell Lymphoma Under New Review Pilot

(FDA.gov) Nov 16, 2018 - The U.S. Food and Drug Administration today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly. “The Real-Time Oncology Review (RTOR) program allows the FDA to access key data prior to the official submission of the application allowing the review team to begin their review earlier and communicate with the sponsor prior to the application’s actual submission,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products.

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FDA Grants Breakthrough Therapy Designation to ADCETRIS® (Brentuximab Vedotin) for Frontline Peripheral T-Cell Lymphomas

(Seattle Genetics) Nov 15, 2018 - Seattle Genetics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ADCETRIS (brentuximab vedotin) for previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with CHP (cyclophosphamide, doxorubicin, and prednisone). The positive topline results of the phase 3 ECHELON-2 clinical trial were announced in October 2018, followed by the submission of a supplemental Biologics License Application (BLA) to the FDA in November 2018. Additional data will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting, December 1-4, 2018 in San Diego, Calif. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL. ADCETRIS is currently not approved for the frontline treatment of PTCL.

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TG Therapeutics Announces Phase I Study of Novel BTK inhibitor, TG-1701, in Patients with Relapsed or Refractory B-cell Malignancies is Open for Enrollment

(Seeking Alpha) Nov 13, 2018 - TG Therapeutics today announced the first Company sponsored Phase I study of its novel, orally available and covalently-bound Bruton Tyrosine Kinase (BTK) inhibitor, TG-1701, is open for enrollment for patients with relapsed or refractory B-cell malignancies.

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Aduro Biotech Presents Preliminary Results from Ongoing Phase 1 Trials of STING agonist ADU-S100 (MIW815) in Patients with Advanced Solid Tumors or Lymphomas

(Aduro) Nov 9, 2018 - Single agent data supports further evaluation of ADU-S100 in combination with checkpoint inhibitor therapies; ADU-S100 is currently in a combination trial with investigational anti-PD-1 monoclonal antibody spartalizumab (PDR001) and with ipilimumab in an ongoing FIH study.

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Verastem Oncology Announces Collaboration with The Leukemia & Lymphoma Society to Accelerate Development of Duvelisib for the Treatment of Peripheral T-Cell Lymphoma

(MarketWatch) Nov 7, 2018 - Verastem, Inc. today announced a collaboration with The Leukemia & Lymphoma Society® (LLS), to accelerate the development of duvelisib for the treatment of patients with peripheral T-cell lymphoma (PTCL), an aggressive type of non-Hodgkin lymphoma (NHL).

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Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

(Karyopharm Therapeutics) Nov 7, 2018 – Karyopharm Therapeutics Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to selinexor, the Company’s first in class, oral SINE compound, for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies and are not eligible for high dose chemotherapy with stem cell rescue or CAR-T therapy.

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BeiGene Initiates Global Head-to-Head Phase 3 Clinical Trial of Zanubrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

(PipelineReview.com) Nov 7, 2018 - BeiGene, Ltd., a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced the first patient was dosed in a global Phase 3 clinical trial of its investigational BTK inhibitor zanubrutinib compared with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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Novartis Abandons Effort For U.S. Approval Of Biosimilar Rituximab

(Reuters) Nov 2, 2018 - Novartis International AG said on Friday that its Sandoz division is abandoning an effort to gain U.S. regulatory approval for a biosimilar of rituximab, a medication used to treat certain cancer and rheumatoid arthritis. The decision comes after the U.S. Food and Drug Administration (FDA) sought additional information to support the company’s application for the drug, which is approved already in the EU, Switzerland, Japan and Australia, the company said in a statement. “We are disappointed to have to make this decision and stand behind the safety, efficacy and quality of our medicine,” said Stefan Hendriks, global head of biopharmaceuticals at Sandoz.

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Sandoz Decides Not To Pursue UsSBiosimilar Rituximab; Will Focus On Robust Biosimilar Portfolio For Unmet Access And Sustainability Needs

(Novartis) Nov 2, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that it will not pursue its submission for biosimilar rituximab in the US at this time. The decision follows a request by the US Food and Drug Administration (FDA) for additional information to complement the submission. "We appreciate the important conversations with the FDA, which have provided specific requirements for our potential US biosimilar rituximab, but believe the patient and marketplace needs in the US will be satisfied before we can generate the data required," said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. "We are disappointed to have to make this decision and stand behind the safety, efficacy and quality of our medicine, which met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand and Australia.

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Takeda to Present Data During 60th American Society of Hematology Annual Meeting on Wide Array of Treatment Needs for Blood Cancers

(Takeda) Nov 1, 2018 - Results from phase 3 studies including TOURMALINE-MM3 Trial of NINLARO™ (ixazomib) as post- autologous stem cell transplant maintenance therapy and ECHELON-2 trial of ADCETRIS® (brentuximab vedotin) in frontline CD30-positive peripheral T-cell lymphoma featured in oral sessions.

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Amgen To Present New Data Showcasing Extensive Portfolio And Exciting Early Oncology Pipeline At ASH 2018

(Amgen) Nov 1, 2018 - Amgen today announced that new clinical data will be presented at the 60th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego, Dec. 1-4, 2018. Data across an array of malignancies will be featured in 45 abstracts, including nine oral presentations, from the Company's broad portfolio and early-stage pipeline.

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Seattle Genetics Submits Supplemental Biologics License Application for ADCETRIS® (Brentuximab Vedotin) in Frontline Treatment of CD30-Expressing Peripheral T-Cell Lymphomas

(Puget Sound Business Journal) Nov 5, 2018 - Submission based on positive phase 3 ECHELON-2 trial evaluating ADCETRIS in frontline CD30-expressing peripheral T-cell lymphoma (PTCL); ECHELON-2 data will be presented at upcoming ASH Annual Meeting in December.

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Anti-CD47 Cancer Therapy Safe, Shows Promise In Small Clinical Trial

(Stanford Medicine) Oct 31, 2018 - A novel immunotherapy appears safe for use in patients with a type of blood cancer called non-Hodgkin’s lymphoma, according to a phase-1 multicenter clinical trial led by a researcher at the Stanford University School of Medicine.

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Gilead to Present Latest Scientific Research in Hematologic Malignancies and Solid Tumors at ASH 2018

(AFP.com) Nov 1, 2018 - Gilead Sciences, Inc. today announced data from its oncology and cell therapy research programs will be presented at the 60th American Society of Hematology (ASH) Annual Meeting & Exposition, in San Diego from December 1 – 4, 2018. Twelve abstracts will be presented, including data highlighting Gilead’s broad cell therapy pipeline in hematologic malignancies and solid tumors.

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Study in JNCCN Identifies Significant Factors for Reducing the Risk of Immunosuppression and Fever in People Being Treated with Chemotherapy

(NCCN) Oct 30, 2018 - Researchers find the timing and length of use for corticosteroids has a particularly strong impact on the likelihood of severe, life-threatening adverse events for people with cancer.

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Seattle Genetics Announces Multiple Data Presentations Evaluating ADCETRIS® (Brentuximab Vedotin) in Patients with Hodgkin Lymphoma at ISHL 2018

(Puget Sound Business Journal) Oct 26, 2018 - Seattle Genetics, Inc. today highlighted multiple presentations evaluating ADCETRIS (brentuximab vedotin) across a broad range of Hodgkin lymphoma (HL) settings at the 11th International Symposium on Hodgkin Lymphoma (ISHL) taking place in Cologne, Germany, October 27-29, 2018.

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Celgene Keys In On ASH For Critical Look At Its Drugs Of The Future

(BioPharmaDive.com) Oct 25, 2018 - For December's ASH conference, Celgene execs said the following clinical trials will roll results out:

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First Presentation of Early Data for Merck’s Investigational STING Agonist (MK-1454) in Patients with Advanced Solid Tumors or Lymphomas at ESMO 2018 Congress

(Merck) Oct 20, 2018 - Merck, known as MSD outside the United States and Canada, today announced the first presentation of preliminary data from a Phase 1 clinical trial evaluating MK-1454, an investigational STING (stimulator of interferon genes) agonist, as monotherapy and in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced solid tumors or lymphomas. MK-1454 is one of more than 20 novel investigational immuno-therapeutic candidates Merck is evaluating as part of its broad oncology pipeline.

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AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA® (ibrutinib) in Combination with Obinutuzumab (GAZYVA®) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

(AbbVie) Oct 17, 2018 - If granted, IMBRUVICA plus obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for first-line CLL treatment. The submission is based on positive results from the Phase 3 iLLUMINATE (PCYC-1130) trial, which showed longer progression-free survival for IMBRUVICA plus obinutuzumab versus chlorambucil plus obinutuzumab in CLL/SLL.

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