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News Release Ariad Announces FDA Acceptance of NDA Filing for Ponatinib in CML and Ph+ALL

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Submitted by sandy craine on Wed, 24/10/2012 - 5:36pm
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 24, 2012-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for accelerated review of ARIAD’s investigational BCR-ABL inhibitor, ponatinib, in patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 24, 2012-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for accelerated review of ARIAD’s investigational BCR-ABL inhibitor, ponatinib, in patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

EPIC- tial open for enrollment: ponatinib vs imatinib in newly diagnosed CML

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Submitted by sandy craine on Wed, 24/10/2012 - 5:28pm
The EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) trial is designed to provide definitive clinical data to support regulatory approval of ponatinib in treatment-naïve CML patients. The efficacy of ponatinib will be assessed in comparison to imatinib based on evaluation of the primary endpoint of major molecular response (MMR) rate at 12 months. ARIAD expects to complete patient enrollment in the trial by the end of 2013.

The EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) trial is designed to provide definitive clinical data to support regulatory approval of ponatinib in treatment-naïve CML patients. The efficacy of ponatinib will be assessed in comparison to imatinib based on evaluation of the primary endpoint of major molecular response (MMR) rate at 12 months. ARIAD expects to complete patient enrollment in the trial by the end of 2013.

Reduced-Intensity Conditioning (RIC) Vs Standard Conditioning pre: Allogeneic Haemopoietic Cell Transplantation in Acute Myeloid Leukaemia in 1st Complete Remission:Lancet Oncol. 2012 Sept 6

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Submitted by sandy craine on Tue, 25/09/2012 - 11:15am
Reduced-Intensity Conditioning Versus Standard Conditioning Before Allogeneic Haemopoietic Cell Transplantation in Patients With Acute Myeloid Leukaemia in First Complete Remission: A Prospective, Open-Label Randomised Phase 3 Trial Lancet Oncol. 2012 Sept 6;[Epub Ahead of Print], M Bornhauser, J Kienast, R Trenschel, et al

Reduced-Intensity Conditioning Versus Standard Conditioning Before Allogeneic Haemopoietic Cell Transplantation in Patients With Acute Myeloid Leukaemia in First Complete Remission: A Prospective, Open-Label Randomised Phase 3 Trial
Lancet Oncol. 2012 Sept 6;[Epub Ahead of Print], M Bornhauser, J Kienast, R Trenschel, et al

2013 European Group for Blood and Marrow Transplantation (EBMT) conference London

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Submitted by sandy craine on Mon, 10/09/2012 - 5:20pm
In April 2013 the annual European Group for Blood and Marrow Transplantation (EBMT) conference will be held in London. As part of this conference, there is a dedicated Patient and Family Day on Saturday 6 April where the content is geared towards people who have had a bone marrow transplant – and of course their families.

In April 2013 the annual European Group for Blood and Marrow Transplantation (EBMT) conference will be held in London. As part of this conference, there is a dedicated Patient and Family Day on Saturday 6 April where the content is geared towards people who have had a bone marrow transplant – and of course their families.

Phase 2 Study of Subcutaneous Omacetaxine Mepesuccinate After TKI Failure in Patients With Chronic-Phase CML With T315I Mutation

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Submitted by sandy craine on Mon, 10/09/2012 - 1:50pm
Phase 2 Study of Subcutaneous Omacetaxine Mepesuccinate After TKI Failure in Patients With Chronic-Phase CML With T315I Mutation Blood. 2012 Aug 15;[Epub Ahead of Print], J Cortes, JH Lipton, D Rea, R Digumarti, C Chuah, N Nanda, AC Benichou, AR Craig, M Michallet, FE Nicolini, H Kantarjian

Phase 2 Study of Subcutaneous Omacetaxine Mepesuccinate After TKI Failure in Patients With Chronic-Phase CML With T315I Mutation
Blood. 2012 Aug 15;[Epub Ahead of Print], J Cortes, JH Lipton, D Rea, R Digumarti, C Chuah, N Nanda, AC Benichou, AR Craig, M Michallet, FE Nicolini, H Kantarjian

Ariad Prepares for Early Launch of CML Drug Ponatinib The Pink Sheet Daily. 2012 Aug 6, E Hayes

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Submitted by sandy craine on Mon, 10/09/2012 - 1:47pm
With an FDA filing of its wholly owned chronic myelogenous leukemia drug ponatinib under its belt, Ariad Pharmaceuticals Inc.says it will be commercially ready in the U.S. by the end of October and hopes to launch in the first quarter of 2013.

With an FDA filing of its wholly owned chronic myelogenous leukemia drug ponatinib under its belt, Ariad Pharmaceuticals Inc.says it will be commercially ready in the U.S. by the end of October and hopes to launch in the first quarter of 2013.

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