Multiple Myeloma

Cellectar Biosciences' CLR 131 Achieves Overall Survival of Greater Than 22 Months in Advanced Multiple Myeloma Patients

(TheStreet) Aug 8, 2017 - Cellectar Biosciences, Inc., an oncology-focused, clinical stage biotechnology company, today announces its lead PDC compound, CLR 131 has achieved a median overall survival of 22.5 months to date after a single dose infusion of 12.5mCi/m2 in patients with multiple myeloma.

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Compound Shows Promise In Treating Melanoma

(Penn State) July 25, 2017 - While past attempts to treat melanoma failed to meet expectations, an international team of researchers are hopeful that a compound they tested on both mice and on human cells in a petri dish takes a positive step toward creating a drug that can kill melanoma cancer cells without harming nearby healthy cells.

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Celgene Settles Whistle-Blower Fraud Suit for $280 Million

(Bloomberg) July 25, 2017 - Celgene Corp. agreed to pay $280 million to resolve a whistle-blower’s claims the drugmaker used illegal marketing tactics to turn its Thalomid and Revlimid cancer drugs into blockbuster sellers, the U.S. said.

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Final NHS Green Light For Amgen’s Kyprolis

(PharmaTimes [UK]) July 20, 2017 - Patients living with multiple myeloma across England and Wales should now get ‘routine’ access to Amgen’s Kyprolis on the NHS within three months following a final green light from the National Institute for Health and Care Excellence.

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U.S. Court Upholds Takeda Patent On Cancer Drug Velcade

(Reuters) July 17, 2017 - A U.S. appeals court ruled on Monday that a patent on Takeda Pharmaceutical Co Ltd's cancer treatment Velcade is valid, pushing back the date when generic drug makers including Teva Pharmaceutical Industries Ltd and Mylan NV will be allowed to launch lower-cost versions of the drug in the United States.

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Amgen Submits Regulatory Applications In US And Europe To Include Overall Survival Data In KYPROLIS® (Carfilzomib) Label

(Amgen) July 14, 2017 - Amgen today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a variation to the marketing application to the European Medicines Agency (EMA) to include overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in the product information for KYPROLIS® (carfilzomib).

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Second Phase 3 Study Shows KYPROLIS® (Carfilzomib) Regimen Significantly Improves Overall Survival In Patients With Relapsed Multiple Myeloma

(Yahoo! Finance) July 12, 2017 - Amgen today announced positive results from the final analysis of the Phase 3 ASPIRE trial. The study met the key secondary endpoint of overall survival (OS), demonstrating that KYPROLIS® (carfilzomib), lenalidomide and dexamethasone (KRd) reduced the risk of death by 21 percent over lenalidomide and dexamethasone alone (Rd) (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 percent CI, 0.67 – 0.95).

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Denosumab Shows Benefits in Multiple Myeloma Bone Disease

(Medscape Medical News) June 27, 2017 - In a head-to-head comparison with zoledronic acid, denosumab was noninferior, with prolonged time to a first skeletal event and a reduced risk for renal events.

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Four-Year Follow-up with Empliciti (elotuzumab) Plus Lenalidomide/Dexamethasone (ELd) in Patients with Advanced Multiple Myeloma Shows Long-term Efficacy in ELOQUENT-2 Trial

(BMS) June 24, 2017 - Combination therapy demonstrated a sustained reduction in risk of progression/death of 29% and relative improvement of 50% in progression-free survival rate of ELd (21%) compared to Ld alone (14%); the extended follow-up data is the longest of an Immuno-Oncology agent in relapsed/refractory multiple myeloma; the data showed a safety profile consistent with prior findings.

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Takeda Pharmaceutical: Presents Data from Phase 1/2 Studies for NINLARO™ (ixazomib) in Newly Diagnosed Multiple Myeloma Patients and in the Maintenance Setting

(4-traders) June 23, 2017 - Early studies of weekly and twice-weekly ixazomib plus lenalidomide and dexamethasone demonstrate deep responses after induction, with deepening responses seen after single-agent ixazomib maintenance; Data to be presented during two oral sessions at the 2017 European Hematology Association (EHA) Annual Meeting.

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Adaptive Biotechnologies Announces a Collaboration with Janssen Biotech, Inc. to use the clonoSEQ Assay to Measure Minimal Residual Disease in Ongoing and Future DARZALEX Multiple Myeloma Trials

(Adaptive Biotechnologies) June 21, 2017 - Adaptive Biotechnologies, the leader in combining Next Generation Sequencing (NGS) and expert bioinformatics to profile T- and B-cell receptors of the adaptive immune system, announces it has partnered with Janssen Biotech, Inc. to utilize Adaptive’s NGS-based clonoSEQ Assay for measuring minimal residual disease (MRD) in patients with Multiple Myeloma (MM) who have been treated with DARZALEX (daratumumab).

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Amgen To Present New Data At 22nd Congress of the European Hematology Association

(Amgen) June 21, 2017 - Amgen today announced that new clinical data and analyses from its hematology portfolio will be presented at the 22nd Congress of the European Hematology Association (EHA) in Madrid, June 22-25, 2017. Key data will be presented from studies evaluating KYPROLIS® (carfilzomib), BLINCYTO® (blinatumomab), XGEVA® (denosumab) and Nplate® (romiplostim).

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FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA® (denosumab) To Include Multiple Myeloma Patients

(Yahoo! Finance) June 19, 2017 — FDA Sets PDUFA target action date of Feb. 3, 2018.

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DARZALEX (daratumumab) Approved by the U.S. FDA in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Who Have Received At Least Two Prior Therapies

(Johnson & Johnson) June 16, 2017 - Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the immunotherapy DARZALEX® (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (an immunomodulatory agent) and a proteasome inhibitor (PI).

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Cancer Patient Sues Celgene For Thwarting Generic Versions Of Its Pricey Meds

(STAT Plus) June 15, 2017 - In what may be a first, a patient has filed a lawsuit accusing a drug maker of hiding behind a mandated safety program to thwart generic competition. The company, in this case, is Celgene.

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Multiple Myeloma Patients to Get NHS Access to Amgen’s Kyprolis

(PharmaTimes [UK]) June 14, 2017 - The National Institute for Health and Care Excellence is backing routine NHS use of Amgen’s Kyprolis as an option for treating patients with multiple myeloma at first relapse.

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Dragonfly, Tyler Jacks’s Disney-Backed Startup, Gets $33M in Celgene Deal

(Xconomy Boston) June 12, 2017 - Dragonfly Therapeutics, a stealthy startup formed by well-known cancer researchers on both coasts and backed by a high-powered group of family offices, has inked its first partnership. Celgene, of Summit, NJ, is paying Dragonfly $33 million up front for the chance to co-develop up to four blood cancer drugs.

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Blood and Bone Marrow Therapies Grab Spotlight At World's Top Cancer Meeting

(Reuters) June 7, 2017 - Promising new data on blood and bone marrow cancer therapies that re-engineer immune system cells are convincing more doctors of the validity of the approach, according to Reuters interviews at the world's biggest annual oncology meeting.

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3 Key Takeaways from the World’s Biggest Cancer Conference

(Fortune) June 6, 2017 - Today is the last day of the annual American Society of Clinical Oncology (ASCO) meeting in Chicago. The yearly confab is the biggest cancer conference in the world, attracting more than 30,000 oncology researchers, biopharma executives, investors, and public health experts.

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Takeda Breaks Ground On $45M Ninlaro Plant In Ireland

(in-PharmaTechnologist.com) June 6, 2017 - Takeda has begun construction of an Irish facility to support production of its orally delivered blood cancer peptide Ninlaro (ixazomib).

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