Multiple Myeloma

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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8 Things Doctors Are Buzzing About At The Biggest Cancer Research Meeting

(Washington Post/To Your Health) June 6, 2017 - Drug combinations and costs are hot topics at the 38,000-doctor-strong ASCO cancer conference in Chicago.

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Bluebird Bio Shares Pop On What CEO Calls ‘Very Exciting’ Cancer News

(CNBC) June 5, 2017 - Bluebird Bio and its partner, Celgene, released positive results from an ongoing study of patients with relapsed/refractory multiple myeloma. The patients have had an "incredible response rate," Bluebird CEO Nick Leschly told CNBC. "We're really trying to harness the immune system to attack your cancer," he said.

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bluebird bio and Celgene Corporation Announce Updated Clinical Results from Ongoing First-in-Human Multicenter Study of bb2121 Anti-BCMA CAR T Cell Therapy in Relapsed/Refractory Multiple Myeloma at ASCO Annual Meeting

(Celgene) June 5, 2017 - bluebird bio, Inc., and Celgene Corporation today announced that updated results from the ongoing CRB-401 Phase 1 clinical study of bb2121, an investigational anti-BCMA CAR T cell therapy, in 18 patients with relapsed/refractory multiple myeloma will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

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A First: All Respond To Gene Therapy In A Blood Cancer Study

(ABC News/Associated Press) June 5, 2017 - Doctors are reporting unprecedented success from a new cell and gene therapy for multiple myeloma, a blood cancer that's on the rise. Although it's early and the study is small—35 people—every patient responded and all but two were in some level of remission within two months.

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Bluebird, Celgene CAR-T Keeps Multiple Myeloma Patients Relapse Free

(TheStreet) June 5,2017 - The negative whispers that hit Bluebird Bio's stock price coming into the American Society of Clinical Oncology (ASCO) annual meeting were wrong. There was nothing much to worry about the company's anti-BCMA CAR-T therapy for multiple myeloma.

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Amgen Presents New Data From Phase 3 XGEVA® (Denosumab) Study In Patients With Multiple Myeloma At ASCO 2017

(Amgen) June 4, 2017 - Amgen today announced new data from the XGEVA® (denosumab) Phase 3 '482 study, the largest international multiple myeloma trial ever conducted.

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Daratumumab Combination Therapy Improved Clinical Outcomes Regardless of Cytogenetic Risk for Previously-Treated Patients with Multiple Myeloma

(Janssen Oncology) June 4, 2017 - Updated analyses of the pivotal Phase 3 POLLUX and CASTOR studies featured as an oral presentation at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting (Abstract 8006); additionally, Phase 1b findings from the MMY1001 clinical trial assessing daratumumab combination therapy for newly diagnosed patients featured as an oral presentation (Abstract 8000).

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International Myeloma Foundation Names Dr. Paul G. Richardson Recipient of the 2017 Robert A. Kyle Lifetime Achievement Award

(IMF) June 1, 2017 - The International Myeloma Foundation (IMF) today announced that Paul G. Richardson, MD, the R.J. Corman Professor of Medicine at Harvard Medical School and Clinical Program Leader / Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute, is the recipient of the 15th annual Robert A. Kyle Lifetime Achievement Award.

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High Costs for Myeloma Patients Not Getting Low-Income Subsidy

(Physician’s Briefing/HealthDay News) May 31, 2017 - There is a substantial financial burden for Medicare beneficiaries with myeloma who do not receive a low-income subsidy (LIS) for orally-administered anticancer therapy, according to a study published online May 25 in the Journal of Clinical Oncology.

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