Tag Archives: acute lymphoblastic leukemia

October, 2018

1 October
FDA Authorizes Adaptive’s clonoSEQ Assay to Detect MRD in Patients with Multiple Myeloma and Acute Lymphoblastic Leukemia

SEATTLE–(BUSINESS WIRE)–Adaptive Biotechnologies® announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo designation for the clonoSEQ® Assay to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from a patient’s bone marrow sample. The clearance …
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30 August
FDA Accepts Bristol-Myers’ sBLA for Sprycel in Pediatric Patients with Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The FDA action date is December …
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2 April
FDA Approves Amgen’s Blincyto to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia

THOUSAND OAKS, Calif., March 29, 2018 /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) for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater …
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5 January
Tumor Suppressor Gene Variants Identified as Cancer ‘Double Whammy’ for Leukemia Patients

Newly identified germline variations in a key tumor suppressor gene predispose individuals to develop leukemia as children and leave them with a 1-in-4 chance of developing a second cancer later. TP scientists led the study, which appears today in the Journal of Clinical Oncology. Researchers sequenced the TP53 tumor suppressor gene in 3,858 children …
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13 December
Kite’s CAR T Therapy Demonstrates High Rates of Response in Patients with Acute Lymphoblastic Leukemia

ATLANTA–(BUSINESS WIRE)–Kite, a Gilead Company (Nasdaq: GILD), announced updated results from the ongoing Phase 1/2 ZUMA-3 study of KTE-C19, a CD19 chimeric antigen receptor T (CAR T) cell therapy, which is investigational for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). With a minimum of …
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31 August
FDA Approves Novartis’ CAR-T Cell Therapy Kymriah for Treatment of B-Cell ALL

novartis Basel, August 30, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) has approved Kymriah(TM)(tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia …
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17 August
Pfizer’s Besponsa Receives FDA Approval for Treatment of Acute Lymphoblastic Leukemia

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1 BESPONSA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs. “The …
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13 July
FDA Committee Recommends Approval for Novartis’ CAR-T Cell Therapy for Acute Lymphoblastic Leukemia

Basel, July 12, 2017 – 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 …
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26 April
FDA Approves Silvergate’s XATMEP, the Only Ready-to-Use Methotrexate Oral Solution

DENVER, April 26, 2017 /PRNewswire/ — Silvergate Pharmaceuticals, Inc. (www.silvergatepharma.com), leaders in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved XATMEP (methotrexate) Oral Solution, the first and only FDA-approved methotrexate oral solution. XATMEP is indicated …
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30 March
Novartis Gains Priority Review from the FDA for its CAR-T Cell Therapy

Basel, March 29, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult …
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