Lymphopenia News and Research

RSS

Lymphopenia is a condition in which there is a lower-than-normal number of lymphocytes (a type of white blood cell) in the blood. Also called lymphocytic leukopenia and lymphocytopenia.

Teva's SYNRIBO for injection receives FDA approval for home administration

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved SYNRIBO® (omacetaxine mepesuccinate) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use.

6 May 2014

European Commission approves Exelixis' COMETRIQ for treatment of progressive, metastatic MTC

Exelixis, Inc. today announced that the European Commission has approved COMETRIQ (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC).

25 Mar 2014

Brazil's ANVISA approves Genzyme's Lemtrada for multiple sclerosis treatment

Genzyme, a Sanofi company, announced today that Brazil's national health surveillance agency, ANVISA, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.

21 Mar 2014

Experimental drug nivolumab shrinks tumors in patients with advanced melanoma

An experimental drug aimed at restoring the immune system's ability to spot and attack cancer halted cancer progression or shrank tumors in patients with advanced melanoma, according to a multisite, early-phase clinical trial at Johns Hopkins Kimmel Cancer Center and 11 other institutions. All patients had experienced disease progression despite prior systemic therapies, and most had received two or more prior treatments.

4 Mar 2014

FDA grants full approval of SYNRIBO for injection

Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has granted full approval of SYNRIBO (omacetaxine mepesuccinate) for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA.

13 Feb 2014

ARIAD Pharmaceuticals' Iclusig now commercially available to patients in the U.S.

ARIAD Pharmaceuticals, Inc. today announced the commercial availability of Iclusig (ponatinib) for adult patients with refractory chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in the United States. ARIAD has begun shipping Iclusig to Biologics, Inc., its exclusive specialty pharmacy, which is now filling prescriptions from physicians and distributing the cancer medicine to patients.

18 Jan 2014

Patient's own bone-marrow stromal cells could treat multi-drug resistant TB

Findings of a preliminary study published in The Lancet Respiratory Medicine suggest that a patient’s own bone-marrow stromal (stem) cells could be used to treat multidrug-resistant (MDR) and extensively-drug (XDR) tuberculosis.

10 Jan 2014

Genzyme gets FDA Complete Response Letter for Lemtrada sBLA

Genzyme, a Sanofi company, announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

30 Dec 2013

Australian Therapeutic Goods Administration approves Genzyme's Lemtrada for multiple sclerosis

Genzyme, a Sanofi company, announced today that the Australian Therapeutic Goods Administration has approved Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.

19 Dec 2013

ARIAD temporarily suspends commercial distribution of Iclusig drug in US

ARIAD Pharmaceuticals, Inc. today announced that it is temporarily suspending the marketing and commercial distribution of Iclusig® (ponatinib), a treatment for patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), in the United States, while it continues to negotiate updates to the U.S. prescribing information for Iclusig and implementation of a risk mitigation strategy.

31 Oct 2013

ARIAD discontinues Phase 3 EPIC trial of Iclusig in patients with chronic myeloid leukemia

ARIAD Pharmaceuticals, Inc. today announced that it is discontinuing the Phase 3 EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) trial of Iclusig (ponatinib) in patients with newly diagnosed chronic myeloid leukemia.

18 Oct 2013

ARIAD announces changes in Iclusig product labeling to reflect updated safety information

ARIAD Pharmaceuticals, Inc. today announced results of its review of updated clinical data from the pivotal PACE trial of Iclusig® (ponatinib) and actions that it is taking following consultations with the U.S. Food and Drug Administration (FDA).

9 Oct 2013

Exelixis starts phase 3 pivotal trial of cabozantinib for treatment of metastatic renal cell carcinoma

Exelixis, Inc. today announced it has initiated METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with metastatic renal cell carcinoma who have experienced disease progression following treatment with at least one prior VEGFR tyrosine kinase inhibitor.

31 May 2013

FDA grants accelerated approval to ARIAD’s Iclusig for treatment of CML, Ph+ ALL

ARIAD Pharmaceuticals, Inc. today announced that following a priority review, the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Iclusig (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.

14 Dec 2012

Blocking myeloid-derived suppressor cells after lymphopenia improves adoptive T-cell therapy

Researchers at the Moffitt Cancer Center have found that delayed tumor growth and enhanced survival of mice bearing melanoma were possible by blocking the reconstitution of myeloid-derived suppressor cells and Tregs (suppressors of anti-tumor activity) after total body irradiation had eliminated them. Blocking myeloid-derived suppressor cells and regulatory T-cell reconstitution improved adoptive T-cell therapy, an immunotherapy designed to suppress tumor activity.

12 Dec 2012

Janssen receives FDA approval for ZYTIGA to treat metastatic castration-resistant prostate cancer

Janssen announced today that the U.S. Food and Drug Administration (FDA) has approved a broader indication for the oral, once-daily medication ZYTIGA (abiraterone acetate).

10 Dec 2012

Exelixis announces FDA approval of COMETRIQ for treatment of medullary thyroid cancer

Exelixis, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved COMETRIQ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

30 Nov 2012

European Medicines Agency accepts Exelixis’ COMETRIQ MAA for review

Exelixis, Inc. today announced the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for COMETRIQ (cabozantinib) for the proposed indication of treatment of progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).

29 Nov 2012

Lymphopenia driven diseases and the orphan drug industry: an interview with Damian Marron, CEO of Cytheris

Lymphopenia is when you lack the T cells of your immune system. T cells are very important for controlling infection. Probably the most known cause of lymphopenia is HIV.

23 Nov 2012

Combination of perifosine and temsirolimus shows promise against malignant glioma

Aeterna Zentaris Inc. today announced that perifosine, its oral AKT inhibitor, combined with temsirolimus ("TEM"), was well tolerated in an investigator driven Phase 1 clinical trial in recurrent or progressive malignant glioma ("MG").

20 Nov 2012