Tag Archives: non-hodgkin’s lymphoma

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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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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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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20 July
Kite’s CAR-T Cell Therapy Demonstrates Positive Results in Patients with Chemorefractory Aggressive NHL

SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite Pharma, Inc. (Nasdaq:KITE), a leading cell therapy company, highlighted the recent online publication of results in Molecular Therapy from a National Cancer Institute (NCI) study of anti-CD19 chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive NHL including diffuse large B-cell lymphoma (DLBCL). The research, led by James …
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30 March
Genmab Discontinues Mid-Stage Non-Hodgkin’s Lymphoma Study

Copenhagen, Denmark; March 30, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its collaboration partner for daratumumab, Janssen Biotech, Inc., has decided not to initiate stage 2 of the Phase II study (CARINA, LYM2001) of daratumumab in three types of relapsed or refractory non-Hodgkin’s lymphoma (NHL). The study …
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25 November
Genmab Halts Late-Stage Lymphoma Trial

Copenhagen, Denmark; November 23, 2015 – Genmab A/S (OMX: GEN) announced today that the Phase III study of single agent ofatumumab compared to single agent rituximab in patients with follicular non-Hodgkin’s lymphoma (NHL) that has relapsed at least 6 months after completion of treatment with a rituximab-containing regimen will be stopped …
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