Tag Archives: NHL

November, 2018

29 November
FDA Approves Celltrion’s Truxima, a Biosimilar to Rituxan, for Treatment of Adult Patients with Non-Hodgkin’s Lymphoma

INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE)–Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved TRUXIMA® (rituximab-abbs), a monoclonal antibody (mAb) biosimilar to RITUXAN®1 (rituximab) for the treatment of adult patients in three indications: Relapsed or refractory, low-grade or follicular, CD20-positive, …
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8 November
Verastem and The Leukemia & Lymphoma Society Partner to Accelerate Development of Duvelisib for the Treatment of Peripheral T-Cell Lymphoma

BOSTON, Mass.–(BUSINESS WIRE)–Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced a collaboration with The Leukemia & Lymphoma Society® (LLS), to accelerate the development of duvelisib for the treatment of patients …
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25 September
FDA Lifts Clinical Hold on Epizyme’s Tazemetostat Program in Follicular Lymphoma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Epizyme, Inc. (NASDAQ: EPZM), a clinical-stage company developing novel epigenetic therapies, today announced the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials. Epizyme is now in the process of reopening enrollment …
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27 August
FDA Approves Imbruvica Plus Rituximab for Treatment of Adults with Waldenström’s Macroglobulinemia

NORTH CHICAGO, Ill., Aug. 27, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) plus rituximab (RITUXAN®) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM), a rare and incurable type of non-Hodgkin’s lymphoma (NHL). With this approval, the …
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9 August
FDA Approves Kyowa Kirin’s Poteligeo for Treatment of Two Rare Types of Non-Hodgkin Lymphoma

TOKYO, Aug. 8, 2018 /PRNewswire/ — Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Poteligeo® (mogamulizumab-kpkc) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one …
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10 July
CTI BioPharma’s Pixurvi Fails to Meet Primary Endpoint in Phase 3 Non-Hodgkin Lymphoma Trial

PARIS–(BUSINESS WIRE)–CTI BioPharma Corp. and Servier today announced that the pivotal Phase III study (PIX306) evaluating PIXUVRI® (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint of improvement of progression-free survival (PFS). “We are …
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11 December
Juno Therapeutics and Celgene Release Additional Data from its Trial of JCAR017 in Aggressive B-Cell NHL

SEATTLE & SUMMIT, N.J.–(BUSINESS WIRE)–Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, and Celgene Corporation (NASDAQ: CELG) today released additional data from the TRANSCEND study of JCAR017 (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory (r/r) aggressive B-cell non-Hodgkin lymphoma …
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7 December
Foundation Medicine to Present New Data Supporting FoundationOne®Heme to Advance Personalized Medicine in Blood Cancers

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. (NASDAQ:FMI) today announced that new data generated with FoundationOne®Heme, its comprehensive genomic profiling (CGP) assay for hematologic malignancies and sarcomas, will be presented at the American Society of Hematology (ASH) Annual Meeting. Data from a broad range of blood cancers, including acute myeloid leukemia (AML), myeloproliferative …
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13 September
FDA Accepts for Review Sandoz’s BLA for Proposed Biosimilar Rituximab

Holzkirchen, September 12, 2017 – Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan®** (rituximab). Rituxan®** is used to …
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28 August
FDA Grants Priority Review for Genentech’s Gazyva in Previously Untreated Follicular Lymphoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Gazyva® (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for …
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