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Amgen’s Blincyto approved by FDA for new acute lymphoblastic leukaemia indication

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Amgen’s Blincyto (blinatumomab) has been granted approval by the US Food and Drug Administration (FDA) to treat adult and paediatric patients aged one month and older with an aggressive type of blood cancer.

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PM Live

FDA Approves Iclusig for New Patients with Aggressive Leukemia

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The FDA has granted an accelerated approval for a supplemental indication for Iclusig (ponatinib). It is now approved to treat adult patients who have been newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). Iclusig is indicated to be used in combination with chemotherapy.

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Managed Healthcare Executive

Takeda's Iclusig shows potential to become standard of care in acute lymphoblastic leukemia subtype

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In November, Takeda said its blood cancer drug Iclusig topped Novartis’ Gleevec in a phase 3 trial in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL).

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Fierce Pharma

Jazz plays coda to blood cancer approval, securing FDA nod for revised dosing schedule

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Jazz Pharmaceuticals has won FDA approval for a revised dosing schedule for its blood cancer therapy Rylaze, giving physicians the option to prescribe intramuscular doses of the drug on Monday, Wednesday and Friday.

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Fierce Pharma

Takeda touts positive first-line leukemia results — but isn't quite ready to reveal the hard data

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Five years after shelling out more than $5 billion for Ariad Pharmaceuticals and its rare leukemia drug Iclusig, Takeda is setting plans in motion for a potential label expansion into the first-line setting — but for now, the pharma giant is keeping its cards close.

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Endpoints

Kite gets US FDA approval for Tecartus to treat acute lymphoblastic leukemia

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Kite, a subsidiary of Gilead Sciences, has received the US Food and Drug Administration (FDA) approval for its Tecartus (brexucabtagene autoleucel) to treat patients with relapsed or refractory b-cell acute lymphoblastic leukemia (ALL).

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Pharmaceutical Business Review

Jazz Pharma (JAZZ) Gets FDA Approval for Leukemia Drug Rylaze

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Jazz Pharmaceuticals plc JAZZ announced that the FDA has granted approval to a biologics license application (BLA) seeking approval of its novel asparaginase, Rylaze (JZP-458). The drug will likely be available from mid-July as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients (aged one month or more) who are hypersensitive to E. coli-derived asparaginase products.

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Yahoo/Zacks.com

The FDA Accepts Bristol-Myers Squibb’s Application for Sprycel in Ph+ Acute Lymphoblastic Leukemia

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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 29, 2018.

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CP Wire

The FDA Accepts Bristol-Myers Squibb’s Application for Sprycel in Ph+ Acute Lymphoblastic Leukemia


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 29, 2018.

Novartis announces new €78m plant and 450 new jobs to manufacture Kymriah in EU

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Novartis has announced today that the European Commission has approved Kymriah (tisagenlecleucel) for the treatment of acute lymphoblastic leukemia in children and adults up to 25 years of age.

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GoinPharma