Lymphopenia News and Research

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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.

United Therapeutics announces FDA approval of dinutuximab for treatment of high-risk neuroblastoma

United Therapeutics Corporation announced today that the United States Food and Drug Administration has approved Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

10 Mar 2015

Phase 3 COU-AA-302 results show ZYTIGA plus prednisone prolongs overall survival in men with chemotherapy-naive mCRPC

A final analysis of the Phase 3 COU-AA-302 trial presented today at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain showed that ZYTIGA® (abiraterone acetate) plus prednisone significantly prolonged overall survival (OS), compared to an active control of placebo plus prednisone, in men with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC).

30 Sep 2014

Newborn screening for SCID holds promise that affected children can lead healthy lives

Using population-based screening outcomes of approximately 3 million infants, a team of scientists across 14 states, including four researchers at the University of Massachusetts Medical School, have shown that newborn screening for severe combined immunodeficiency (SCID) can be successfully implemented across public health newborn screening programs.

21 Aug 2014

Newborn screening indicates that incidence of SCID is higher than previously believed

Newborn screening performed in numerous states indicates that the incidence of the potentially life-threatening disorder, severe combined immunodeficiency, is higher than previously believed, at 1 in 58,000 births, although there is a high rate of survival, according to a study in the August 20 issue of JAMA.

20 Aug 2014

Lymphocyte count predicts papillary RCC patient survival

Lymphopenia is a significant predictor of outcome in patients undergoing surgery for papillary renal cell carcinoma, US researchers report.

18 Aug 2014

Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).

25 Jul 2014

ANMAT approves Genzyme’s Lemtrada for treatment of relapsing remitting multiple sclerosis

Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that Argentina's National Administration of Drugs, Food and Medical Technology (ANMAT) has approved LemtradaTM (alemtuzumab) for adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

30 Jun 2014

ARIAD reports data from Iclusig Phase 2 trial in adult patients with gastrointestinal stromal tumors

ARIAD Pharmaceuticals, Inc. today announced, for the first time, data from its Phase 2 trial of Iclusig (ponatinib) in adult patients with refractory metastatic and/or unresectable gastrointestinal stromal tumors (GIST).

2 Jun 2014

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