FDA panel recommends approval for gene-altering cancer treatment
An FDA advisory panel yesterday recommended approval for Novartis‘ (NYSE:NVS) CAR-T gene therapy. If approved, it would be the first ever treatment of its kind on the market.
The panel voted unanimously, 10-0, to recommend that the FDA give its official nod. The company’s therapy genetically alters a patient’s own cells to fight acute lymphoblastic leukemia.
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The post FDA panel recommends approval for gene-altering cancer treatment appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - July 13, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Oncology Regulatory/Compliance Wall Street Beat Novartis Source Type: news
Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat pediatric, young adult r/r B-cell ALL
Novartis announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). (Source: World Pharma News)
Source: World Pharma News - July 12, 2017 Category: Pharmaceuticals Tags: Featured Novartis Business and Industry Source Type: news
FDA Grants Full Approval for BLINCYTO ® (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children
BLINCYTO is the First-and-Only Bispecific T Cell Engager (BiTE®) Immunotherapy to Demonstrate Superior Overall Survival Versus Standard of Care Chemotherapy
Data From the Phase 3 TOWER Study Support Conversion From Accelerated to Full Approval
Indication Expansion Underscores Need for Effective Treatment Options
THOUSAND OAKS, Calif., July 11, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include overall survival (OS) data from the Phase 3 TOWER study. T...
Source: Amgen News Release - July 11, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
Novartis readies for FDA review of $1 billion CAR-T child cancer hope
ZURICH (Reuters) - Two decades ago in a Memphis, Tenn., hospital lab, cancer scientist Dario Campana and his team were hunting for a new way to fight deadly acute lymphoblastic leukemia (ALL). (Source: Reuters: Health)
Source: Reuters: Health - July 11, 2017 Category: Consumer Health News Tags: healthNews Source Type: news
FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children
THOUSAND OAKS, Calif., July 11, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) to include... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 11, 2017 Category: Drugs & Pharmacology Source Type: news
BESPONSA ® approved in the EU for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia
Pfizer Inc. (NYSE:PFE) announced that the European Commission has approved BESPONSA® (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). This indication includes treatment of adults with Philadelphia chromosome positive (Ph+) as well as Philadelphia chromosome negative (Ph-) relapsed or refractory B-cell precursor ALL. (Source: World Pharma News)
Source: World Pharma News - July 7, 2017 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news
EC approves Pfizer ’s acute lymphoblastic leukemia treatment Besponsa
The European Commission (EC) has approved Pfizer ’s Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL) in the European Union (EU). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - July 3, 2017 Category: Pharmaceuticals Source Type: news
First large-scale genomic analysis of key acute leukemia will likely yield new therapies
(St. Jude Children's Research Hospital) Charting the genomic landscape of T-lineage acute lymphoblastic leukemia patients revealed insights that will guide research and help to lay the foundation for more targeted therapy. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 3, 2017 Category: International Medicine & Public Health Source Type: news
Adult ALL Patients Benefited From Pediatric Regimen Treatment Intensification
Adult patients with early thymic precursor (ETP) acute lymphoblastic leukemia (ALL), a subgroup of T-cell ALL, could benefit from the use of response-based risk stratification and therapy intensification similar to that used in pediatric patients with ETP-ALL. (Source: CancerNetwork)
Source: CancerNetwork - June 27, 2017 Category: Cancer & Oncology Authors: Leah Lawrence Tags: Hematologic Malignancies Leukemia & Lymphoma News Source Type: news
Amgen To Present New Data At 22nd Congress of the European Hematology Association
Oral Presentation of Phase 3 Data Shows KYPROLIS® (Carfilzomib) and Dexamethasone Improved Median Overall Survival by 7.6 Months Compared to Velcade® (Bortezomib) and Dexamethasone in Relapsed Multiple Myeloma
New Subset Analysis Demonstrates BLINCYTO® (Blinatumomab) More Than Doubled Median Overall Survival Versus Standard of Care Chemotherapy in Adult Patients With Relapsed/Refractory Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in First Salvage
Oral Presentation of New Data From Head-to-Head Phase 3 Study of XGEVA® (Denosumab) Versus Zoledronic Acid in Time to First On-Study Skeletal-Related Eve...
Source: Amgen News Release - June 21, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news
New cancer drug tested in mice may benefit certain leukemia patients
(University of Utah Health) Scientists have found up to 30 percent of adult acute lymphoblastic leukemia or ALL patients have Philadelphia chromosome, where two segments of chromosomes have aberrantly fused together. Adult ALL patients often see high relapse rates, and treatment-related deaths remain high. Researchers at Huntsman Cancer Institute (HCI) at the University of Utah have discovered new science, published this week in the journal Leukemia, that could provide better therapeutic options for patients. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - June 9, 2017 Category: Cancer & Oncology Source Type: news
MRD Status Indicated Therapeutic Benefit in Pediatric, Adult ALL
There is considerable value in having achieved a minimal residual disease negativity for pediatric and adult patients with acute lymphoblastic leukemia. (Source: CancerNetwork)
Source: CancerNetwork - May 14, 2017 Category: Cancer & Oncology Authors: Leah Lawrence Tags: Hematologic Malignancies Leukemia & Lymphoma News Source Type: news
Trial aims to extend remission for children treated with T-cell immunotherapy for leukemia
(Seattle Children's) After phase 1 results of Seattle Children's Pediatric Leukemia Adoptive Therapy (PLAT-02) trial have shown T-cell immunotherapy to be effective in getting 93 percent of patients with relapsed or refractory acute lymphoblastic leukemia into complete initial remission, researchers have now opened a first-in-human clinical trial aimed at reducing the rate of relapse after the therapy, which is about 50 percent. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - May 9, 2017 Category: Biology Source Type: news
Inflammation Linked to Cognitive Difficulties in Childhood ALL Survivors
Female survivors of childhood acute lymphoblastic leukemia were at risk for neurocognitive impairment and were more susceptible to the effects of sleep disturbance and fatigue compared with their male counterparts. (Source: CancerNetwork)
Source: CancerNetwork - May 8, 2017 Category: Cancer & Oncology Authors: Leah Lawrence Tags: Hematologic Malignancies Leukemia & Lymphoma News Pediatric Cancers Survivorship Source Type: news
Genome-wide identification and characterization of Notch transcription complex-binding sequence-paired sites in leukemia cells
Notch transcription complexes (NTCs) drive target gene expression by binding to two distinct types of genomic response elements, NTC monomer–binding sites and sequence-paired sites (SPSs) that bind NTC dimers. SPSs are conserved and have been linked to the Notch responsiveness of a few genes. To assess the overall contribution of SPSs to Notch-dependent gene regulation, we determined the DNA sequence requirements for NTC dimerization using a fluorescence resonance energy transfer (FRET) assay and applied insights from these in vitro studies to Notch-"addicted" T cell acute lymphoblastic leukemia (T-ALL) cells. We fou...
Source: Signal Transduction Knowledge Environment - May 2, 2017 Category: Science Authors: Severson, E., Arnett, K. L., Wang, H., Zang, C., Taing, L., Liu, H., Pear, W. S., Shirley Liu, X., Blacklow, S. C., Aster, J. C. Tags: STKE Research Articles Source Type: news
