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FDA approves Gazyva – a new treatment of chronic lymphocytic leukaemia

FDA approves Gazyva – a new treatment of chronic lymphocytic leukaemia

Publish date: 2013-11-04

On 1 November 2013, Genentech announced that the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab) to be used with chlorambucil chemotherapy for the treatment of chronic lymphocytic leukemia (CLL).

Tags: cancer , leukemia , CLL , antibody , Genentech , Roche , chemoterapy

On 1 November 2013, Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) accepted Gazyva (obinutuzumab), also known as GA101. It is designed to be used with chlorambucil chemotherapy for the treatment of chronic lymphocytic leukemia (CLL). Gazyva is the first drug with breakthrough therapy designation to receive FDA approval. Now, it remains under review by the European Medicines Agency, whose recommendation is usually followed by the the European Commission, the decision-maker for drug marketing across the European Union.

B-lymphocyte antigen CD20 is expressed on the surface of all B-cells during all stages of its development except the first and the last. Gazyva is a new monoclonal antibody that attach to CD20. Therefore, it helps certain immune system cells to attack cancer cells.

 

Chronic Lymphocytic Leukemia (CLL)

The prevalent  form of  blood cancer. According to the National Cancer Institute, 15,680 new cases and 4,580 deaths are expected in 2013 in America. The average age of diagnosis is 71-74. Most people are diagnosed without symptoms as the result of a routine blood test that returns a high white blood cell count.

CLL is generally considered incurable. It progresses slowly in most cases. Treatment is focused on controlling the disease and its symptoms. 

 

Gazyva Efficacy In CLL

Phase III clinical data proved that Gazyva in combination with chlorambucil chemotherapy helped people with CLL live longer without the disease getting worse than chlorambucil chemotherapy alone.

According to the Genentech, Overal Response Rate (ORR) after the treatment with Gazyva + clb increased from 32.1% to 75.9% versus clb alone. What is important, 27.8% of  patients receiving Gazyva had a complete response which means all evidence of the cancer is gone for a period of time. In the case of patients receiving chlorambucil alone it is only 0.9%.

 

GA 101 Side Effects

The most common side effects observed in participants treated with Gazyva were infusion reactions, low blood cell counts, fever, cough, muscle and joint pain. Nonetheless, there are some serious side effects possible including  Progressive Multifocal Leukoencephalopathy (PML) and Tumor Lysis Syndrome (TLS). What is more, if a patient have had hepatitis B or is a carrier of HBV, receiving Gazyva could cause the virus to become an active infection again.

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2018-10-10 07:59:47 +0200
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2016-04-03 03:53:15 +0200
'After being in relationship with Wilson for seven years,he broke up with me, I did everything possible to bring him back but all was in vain, I wanted him back so much because of the love I have for him, I begged him with everything, I made promises but he refused. I explained my problem to someone online and she suggested that I should contact a spell caster that could help me cast a spell to bring him back but I am the type that don't believed in spell, I had no choice than to try it, I meant a spell caster called Dr Zuma zuk and I email him, and he told me there was no problem that everything will be okay before three days, that my ex will return to me before three days, he cast the spell and surprisingly in the second day, it was around 4pm. My ex called me, I was so surprised, I answered the call and all he said was that he was so sorry for everything that happened, that he wanted me to return to him, that he loves me so much. I was so happy and went to him, that was how we started living together happily again. Since then, I have made promise that anybody I know that have a relationship problem, I would be of help to such person by referring him or her to the only real and powerful spell caster who helped me with my own problem and who is different from all the fake ones out there. Anybody could need the help of the spell caster, his email: spiritualherbalisthealing@gmail.com or call him +2349055637784 you can email him if you need his assistance in your relationship or anything. CONTACT HIM NOW FOR SOLUTION TO ALL YOUR PROBLEMS'
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