All posts by: Michael Zand

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FDA Approves CAR-T Therapy Tisagenlecleucel for B-Cell Acute Lymphoblastic Leukemia – Cancer Therapy Advisor

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2017-08-30 NEWS

Cancer Therapy Advisor

FDA Approves CART Therapy Tisagenlecleucel for B-Cell Acute Lymphoblastic Leukemia
Cancer Therapy Advisor
This approval marks the first chimeric antigen receptor T cell (CAR-T) therapy, which utilizes the patients’ own genetically-modified Tcells to target the CD19 antigen on the surface of leukemia cells. Once modified, the cells are injected back into

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2017-08-30 NEWS

FDA approves revolutionary new cell-modifying cancer treatment
The Week Magazine
On Wednesday, the Food and Drug Administration approved a revolutionary new type of cancer treatment that genetically modifies the body’s own cells. The treatment, known as CART therapy, is the first type of gene therapy approved in the U.S and will

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2017-08-30 NEWS

MedPage Today

FDA Approves CAR T-Cell Therapy for Leukemia
MedPage Today
WASHINGTON — The FDA on Wednesday approved a chimeric antigen receptor (CAR) T-cell therapy for treatment of certain pediatric and young adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Calling it a “historic …
First CAR T-Cell ‘Living Drug’ Approved by FDAMedscape
FDA clears first gene-altering therapy — ‘a living drug’ — for childhood leukemiaWashington Post
FDA Approves First Gene Therapy For LeukemiaNPR
OncLive –The Scientist –FDA.gov –National Cancer Institute
all 656 news articles »
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2017-08-30 NEWS

NPR

FDA Approves First Cell-Based Gene Therapy For Cancer
NPR
The Food and Drug Administration on Wednesday announced what the agency calls a “historic action” — the first approval of a cell-based gene therapy in the United States. The FDA approved Kymriah, which scientists refer to as a “living drug” because it …
FDA approval brings first gene therapy to the United StatesFDA.gov
The FDA Has Approved the First Gene Therapy for CancerMIT Technology Review
FDA announces first US gene therapy approval for cancer treatmentCNN
PBS NewsHour –CBS News –Science Magazine –Novartis
all 98 news articles »
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2017-08-30 NEWS

Medscape

First CAR T-Cell ‘Living Drug’ Approved by FDA
Medscape
The first Tcell therapy that uses chimeric antigen receptor (CAR) technology has been approved today by the US Food and Drug Administration (FDA), paving the way for the other products using this novel approach that are in development. “We’re entering
FDA approval brings first gene therapy to the United StatesFDA.gov
Novartis receives first ever FDA approval for a CART cell therapy, Kymriah(TM) (CTL019), for children and young …GlobeNewswire (press release)
A cancer treatment that one expert called the ‘most exciting thing I’ve seen in my lifetime’ just got approvedMarkets Insider
Chicago Tribune –AJMC.com Managed Markets Network –OncLive
all 51 news articles »
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2017-08-30 NEWS

US clears breakthrough gene therapy for childhood leukemia
Press of Atlantic City
The Food and Drug Administration called the approval historic, the first gene therapy to hit the U.S. market. Made from scratch for every patient, it’s one of a wave of “living drugs” under development to fight additional blood cancers and other tumors