Alemtuzumab News and Research

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New study reveals way to combat drug-resistant tumors

Cancer drugs that recruit antibodies from the body's own immune system to help kill tumors have shown much promise in treating several types of cancer. However, after initial success, the tumors often return.

31 Jan 2014

Viewpoints: Is overhaul really a 'war' on the young?; war on poverty requires spending; maternity leave in America

A long-shot lawsuit that could have damaged the effectiveness of health care reform got a well-deserved brushoff from a federal district judge on Wednesday.

20 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

Health Canada approves Genzyme's Lemtrada for adults with relapsing remitting multiple sclerosis

Genzyme, a Sanofi company, announced today that Health Canada has approved Lemtrada (alemtuzumab) for the management of adult patients with relapsing remitting multiple sclerosis, with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.

13 Dec 2013

EMA's CHMP issues positive opinion for approval of Genzyme's LEMTRADA in Europe

Genzyme, a Sanofi company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for approval of LEMTRADA (alemtuzumab) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features.

28 Jun 2013

Genmab, ADC Therapeutics agree to develop new antibody-drug conjugate product

Genmab A/S and ADC Therapeutics Sarl, announced today an agreement to develop a new antibody-drug conjugate product combining Genmab's HuMax-TAC antibody and ADC Therapeutics' PBD-based warhead and linker technology.

17 Jun 2013

FDA accepts Genzyme’s LEMTRADA sBLA for review

Genzyme, a Sanofi Company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental Biologics License Application (sBLA) file seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS).

28 Jan 2013

Lymphocyte clue to multiple sclerosis drug response

Patients with rapid recovery of CD4-positive T cells after alemtuzumab treatment for multiple sclerosis are at risk for disease progression or relapse, research suggests.

18 Dec 2012

Doctors should use different therapies when treating older and younger patients with CLL

Doctors should use different therapies when treating older and younger patients with chronic lymphocytic leukemia, according to a new study led by researchers at the Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC - James).

13 Dec 2012

Caution over monoclonal antibody treatment for MS

Alemtuzumab, an anti-CD52 monoclonal antibody, provides a more effective treatment for individuals with relapsing‑remitting multiple sclerosis than the immunomodulating drug interferon beta 1a, but has significant side effects, show findings from a phase III trial.

12 Nov 2012

Multiple sclerosis disease activity reduced by leukaemia drug, even when first-line treatment has failed

A drug which was originally developed to treat leukaemia and other cancers of the immune system offers substantial improvements over existing treatments in reducing relapse rates for people with multiple sclerosis (MS), even when they have not responded well to first-line treatment, according to the results of two phase 3 trials published Online First in The Lancet.

1 Nov 2012

New data from Genzyme's AUBAGIO and LEMTRADA clinical trials to be presented at ECTRIMS

Genzyme, a Sanofi company, announced today new data from Genzyme's clinical development programs for AUBAGIO (teriflunomide) and LEMTRADATM (alemtuzumab) will be presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France, October 10-13.

9 Oct 2012

Genzyme receives Refuse to File letter from FDA for LEMTRADA

Genzyme, a Sanofi company, announced it has received a Refuse to File letter from the U.S. Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of LEMTRADA (alemtuzumab) as a treatment for relapsing multiple sclerosis.

27 Aug 2012

FORMA, TD2 leverage synergistic capabilities to jointly develop transformative cancer therapies

FORMA Therapeutics and TGen Drug Development (TD2) today announced an agreement to jointly develop transformative cancer therapies, leveraging the synergistic capabilities of both organizations.

19 Jun 2012

Genzyme files LEMTRADA sBLA and MAA with FDA, EMA for treatment of RMS

Genzyme, a Sanofi company, today announced that the company has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of LEMTRADA (alemtuzumab) for treatment of relapsing multiple sclerosis (RMS).

12 Jun 2012

Panel of HuCAL Anti-Drug Antibodies to be launched by AbD Serotec

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that its division for research and diagnostic antibodies, AbD Serotec, will launch a series of novel anti-drug antibodies (ADAs) to strengthen its position as a leading provider of diagnostic reagents.

23 May 2012

Genzyme's alemtuzumab Phase lll trial on MS meets co-primary endpoints

Genzyme, a Sanofi company, reports today that the Phase lll CARE-MS ll trial met both of its co-primary endpoints. Relapse rate and sustained accumulation (worsening) of disability (SAD) were significantly reduced in multiple sclerosis patients receiving alemtuzumab as compared with Rebif.

14 Nov 2011

Sanofi announces new results from alemtuzumab-Rebif comparative CARE-MS I trial

Sanofi and its subsidiary Genzyme announced today new results from the CARE-MS I trial, the first of two randomized, Phase III clinical trials comparing the investigational drug alemtuzumab to Rebif (high dose subcutaneous interferon beta-1a) in patients with relapsing-remitting multiple sclerosis.

22 Oct 2011

Positive top-line results from alemtuzumab Phase 3 trial on multiple sclerosis

Sanofi and its subsidiary Genzyme announced today positive top-line results from CARE-MS I, the first of two randomized, Phase 3 clinical trials comparing the investigational drug alemtuzumab to the approved multiple sclerosis therapy Rebif in patients with relapsing-remitting multiple sclerosis.

11 Jul 2011