Specialty Pharma Journal Specialty, Precision & Technology
BEERSE, Belgium–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 3 MAIA study demonstrating that the addition of daratumumab to lenalidomide and dexamethasone (Rd) significantly reduced the risk of disease progression or death in patients with newly diagnosed multiple myeloma who are ineligible for …
Tag Archives: multiple myeloma
December, 2018
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5 December
Amgen Announces First-In-Human Data Evaluating Investigational Novel BiTE Immunotherapies AMG 420 And AMG 330
THOUSAND OAKS, Calif., Dec. 3, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the first clinical results from studies evaluating investigational novel bispecific T cell engager (BiTE®) immunotherapies AMG 420 and AMG 330. In two separate Phase 1 dose escalation studies, AMG 420, which targets B-cell maturation antigen (BCMA), and AMG 330, which targets CD33, …
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5 December
bluebird bio and Celgene Corporation Present Initial Data from Ongoing Phase 1 Study of Anti-BCMA CAR T Cell Therapy bb21217 in Patients with Multiple Myeloma
CAMBRIDGE, Mass. & SUMMIT, N.J.–(BUSINESS WIRE)–bluebird bio, Inc. (Nasdaq:BLUE) and Celgene Corporation (NASDAQ:CELG) announced initial data from the ongoing Phase 1 clinical study of bb21217 (CRB-402), an investigational next-generation anti-BCMA CAR T cell therapy being studied in patients with relapsed/refractory multiple myeloma. The data were presented by Nina Shah, M.D., …
November, 2018
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7 November
FDA Approves Empliciti Plus Pomalidomide and Dexamethasone for Certain Patients with Relapsed or Refractory Multiple Myeloma
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome …
October, 2018
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30 October
Genmab Announces Positive Topline Results in Phase III Study of Daratumumab in Front Line Multiple Myeloma
Copenhagen, Denmark; October 29, 2018 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today topline results from the Phase III MAIA study (MMY3008) of daratumumab in combination with lenalidomide and dexamethasone (DRd) versus Rd alone as treatment for newly diagnosed patients who are not candidates for high dose chemotherapy and autologous stem …
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24 October
Revlimid Demonstrated a Significant Improvement in Progression-Free Survival Compared with Observation in Patients with Smoldering Multiple Myeloma
SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ: CELG) today announced results from an open-label phase II/III National Clinical Trials Network (NCTN) study led by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. REVLIMID® (lenalidomide) was provided by Celgene under a clinical …
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3 October
Cellectar Announces Overall Survival Exceeding 19 Months in Phase 1b Trial with CLR 131 in Relapsed/Refractory Multiple Myeloma
MADISON, Wis., Oct. 02, 2018 (GLOBE NEWSWIRE) — Cellectar Biosciences (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today updates interim overall survival (OS) data from the company’s ongoing Phase 1b clinical trial evaluating CLR 131 for the …
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3 October
FDA Approves Amgen’s sNDA for Kyprolis in Patients with Relapsed or Refractory Multiple Myeloma
THOUSAND OAKS, Calif., Oct. 1, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma. The …
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1 October
FDA Authorizes Adaptive’s clonoSEQ Assay to Detect MRD in Patients with Multiple Myeloma and Acute Lymphoblastic Leukemia
SEATTLE–(BUSINESS WIRE)–Adaptive Biotechnologies® announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo designation for the clonoSEQ® Assay to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from a patient’s bone marrow sample. The clearance …
September, 2018
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28 September
Study Shows that Measuring MRD Negativity Using Adaptive’s Next-Generation Sequencing Platform is a Major Predictive Indicator in Multiple Myeloma
SEATTLE–(BUSINESS WIRE)–Adaptive Biotechnologies today announced that Blood, the Journal of the American Society of Hematology (ASH), published online an analysis of patient samples from the Intergroupe Francophone du Myéloma (IFM) 2009 trial. The analysis confirms the value of minimal residual disease (MRD) as a prognostic indicator in multiple myeloma (MM) measured …