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AbbVie, Tolero team up to test Venclexta combo in AML fiercebiotech
August 20, 2018
Tolero Pharmaceuticals has inked a pact to test its CDK9 inhibitor, alvocidib, in combination with AbbVie’s BCL-2 blocker Venclexta in relapsed/refractory acute myeloid leukemia (AML). The pair will equally share development costs.
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation pharmatimes
July 23, 2018
The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation.
Priority review for Astellas’ AML drug pharmatimes
June 06, 2018
Astellas Pharma’s gilteritinib is under priority review in the US as potential treatment for adults with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.
U.S. FDA Grants Priority Review to Astellas’ New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) firstwordpharma
May 30, 2018
The NDA is based on the ongoing Phase 3 ADMIRAL trial investigating gilteritinib for the treatment of adult patients with FLT3mut+ relapsed or refractory AML. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is November 29, 2
Singapore researchers discover novel therapeutic pathway biospectrumasia
May 03, 2018
SHARP1 is a protein that plays a role in control of the circadian rhythm in humans. There was no prior association or understanding of its role in AML. The five-year survival rate for the disease is less than 20%.
Pfizer’s Mylotarg wins EU approval for AML pharmatimes
April 26, 2018
European regulators have cleared Pfizer’s Mylotarg to treat a certain subset of patients with acute myeloid leukaemia (AML).
Novel drug shows promise against acute myeloid leukaemia europeanpharmaceuticalreview
April 13, 2018
First of a new class of anti-cancer agents to reach clinical trials…
Trovagene Announces Activation of First Clinical Trial Site in AML Trial americanpharmaceuticacreview
November 14, 2017
Trovagene announced the activation of its clinical trial site for its Phase 1b/2 multicenter trial of PCM-075 in patients with AML, with Virginia Cancer Specialists and Principal Investigator, Dr. Alexander Spira.
Novartis scores EU approval in acute myeloid leukaemia and advanced systemic mastocytosis pharmafile
September 21, 2017
Novartis has announced that its targeted therapy Rydapt (midostaurin) has received EU approval in the two rare cancer indications
FDA puts clinical hold on Cellectis' CAR-T cell therapies biospectrumasia
September 19, 2017
Cellectis said it is working with clinical trial investigators and the FDA to resume the trials with an amended trial protocol that includes a lower dose of UCART123.

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