Specialty Pharma Journal Specialty, Precision & Technology
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 …
Tag Archives: MM
November, 2018
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 …
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 …
July, 2018
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11 July
Takeda’s Ninlaro Met Primary Endpoint in Phase 3 Trial as Maintenance Therapy in Patients with Multiple Myeloma Post-Transplant
CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the randomized, Phase 3 TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral NINLARO®(ixazomib) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) versus placebo. The trial evaluated the effect of …
June, 2018
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11 June
FDA Approves Addition of Positive Overall Survival Data from Phase 3 ASPIRE Trial to Kyprolis Label
THOUSAND OAKS, Calif., June 11, 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 add the positive overall survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for KYPROLIS®(carfilzomib). Data added to the label showed that …
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4 June
FDA Lifts Partial Clinical Hold on Late-Stage Opdivo-Based Combination Study in Multiple Myeloma
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on CA209-602 (CheckMate -602), a randomized, open-label Phase 3 study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. The decision …
November, 2017
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17 November
Celgene and bluebird bio Announce the FDA Granted Breakthrough Therapy Designation to CAR-T Cell Therapy
SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) and bluebird bio, Inc. (NASDAQ:BLUE) today announced that bb2121, a chimeric antigen receptor T-cell (CAR-T) therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration …
October, 2017
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26 October
Amgen’s Kyprolis Meets Primary Endpoint in Phase 3 Study in Relapsed and Refractory Multiple Myeloma
THOUSAND OAKS, Calif., Oct. 23, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced top-line results of the Phase 3 A.R.R.O.W. trial, which showed KYPROLIS® (carfilzomib) administered once-weekly at the 70 mg/m2 dose with dexamethasone allowed relapsed and refractory multiple myeloma patients to live 3.6 months longer without their disease worsening …