CEbiotech.com - Central European Biotechnology Portal
be visible on the BioBusiness market                  ISSN 2300-0228
Green light for Novartis drug “Jakavi” for rare blood cancer treatment

Green light for Novartis drug “Jakavi” for rare blood cancer treatment

Publish date: 2015-03-25

Novartis drug “Jakavi” has been approved by the European Commission for the therapy of rare blood cancer, polycythemia vera. It is the first approved targeted drug for treatment of this disease and it gives hope for patients unresponsive to standard therapy with hydroxyurea.

Tags: drug , cancer , eu , Novartis , targeted therapy , approval

The European Commission has given the approval for Novartis targeted drug “Jakavi” (ruxolitinib) for the treatment of polycythemia vera (PV). The drug has been already recommended by The Committee for Medicinal Products for Human Use (CHMP) for EU approval at the end of January 2015. The positive CHMP opinion was based on clinical trial data revealing that “Jakavi” treatment substantially improves control of the disease mainly by stabilizing hematocrit levels and reducing size of the spleen.

The PV is considered as stem cell disorder characterized as a panhyperplastic, malignant, and neoplastic marrow disorder. This chronic and incurable blood cancer is caused by the disturbances in JAK-STAT signaling pathway that is responsible for the regulation of blood cell production. In PV patients, blood cells are overproduced and their hematocrit, the volume percentage of red blood cells in the whole blood, is most often elevated.

The typical treatment approaches involve phlebotomy that enables removal of the excess of cell elements, especially red blood cells, and the application of so called myelosuppressive agents such as hydroxyurea (HU). However, the phlebotomy cannot be considered as long-term way of treatment as it does not ensure proper symptom control. Additionally, it has been reported that about 25% of patients suffering from PV become resistant or intolerant to such compounds as HU.

“Jakavi”, the drug proposed by Novartis, is a JAK1/JAK2 inhibitor that has been already approved by the Food and Drug Administration (FDA) in December 2014 for treatment of PV patients. The EU approval was based on the data collected during Phase III RESPONSE clinical trial. The application of ruxolitinib has shown that the novel targeted drug therapy resulted in successful hematocrit control and spleen size reduction. Moreover, most patients were characterized by complete hematologic remission that was not achieved to such an extent in standard therapy.

“Jakavi” is the first targeted drug approved by EU for PV treatment. The approval is in force in all 28 EU member states as well as in Iceland, Norway and Liechtenstein.  Positive clinical trial data indicated that targeted therapies may be critical when standard ways of treatment fail. Such results give hope for further development of targeted medicine, especially in the field of cancer.

Sources:

http://www.dddmag.com/news/2015/03/novartis-gains-eu-approval-rare-blood-cancer-drug

http://www.novartis.com/newsroom/media-releases/en/2015/1889065.shtml

http://emedicine.medscape.com/article/205114-overview

Maciej Smolarz

 

Comments:

Add comment
Guest
2018-10-08 16:28:07 +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 +2348164728160 you can email him if you need his assistance in your relationship or anything. CONTACT HIM NOW FOR SOLUTION TO ALL YOUR PROBLEMS
Guest
2016-04-03 04:23:30 +0200
My name is Jessica Luis, and I base in USA...My life is back!!! After 1 years of Broken marriage, my husband left me with two kids . I felt like my life was about to end i almost committed suicide, i was emotionally down for a very long time. Thanks to a spell caster called Dr Mohammed, which i met online. On one faithful day, as I was browsing through the internet,I came across allot of testimonies about this particular spell caster. Some people testified that he brought their Ex lover back, some testified that he restores womb,cure cancer,and other sickness, some testified that he can cast a spell to stop divorce and so on. i also come across one particular testimony,it was about a woman called Sonia,she testified about how he brought back her Ex lover in less than 2 days, and at the end of her testimony she dropped Dr Mohammed's e-mail address. After reading all these,I decided to give it a try. I contacted him via email and explained my problem to him. In just 48hours, my husband came back to me. We solved our issues, and we are even happier than before Dr Mohammed, is really a gifted man and i will not stop publishing him because he is a wonderful man... If you have a problem and you are looking for a real and genuine spell caster to solve all your problems for you. Try High monicaspiritualtemple@gmail.com anytime, he might be the answer to your problems. Here's his contact: monicaspiritualtemple@gmail.com or call him +2348134493948
Guest
2016-04-03 02:42:57 +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'
Mccart2
2015-04-27 21:56:51 +0200
How to get lost love back even if you made some mistakes Am here to testify what this great spell caster done for me. i never believe in spell casting, until when i was was tempted to try it. i and my husband have been having a lot of problem living together, he will always not make me happy because he have fallen in love with another lady outside our relationship, i tried my best to make sure that my husband leave this woman but the more i talk to him the more he makes me fell sad, so my marriage is now leading to divorce because he no longer gives me attention. so with all this pain and agony, i decided to contact this spell caster to see if things can work out between me and my husband again. this spell caster who was a woman told me that my husband is really under a great spell that he have been charm by some magic, so she told me that she was going to make all things normal back. she did the spell on my husband and after 5 days my husband changed completely he even apologize with the way he treated me that he was not him self, i really thank this woman her name is Dr Aluta she have bring back my husband back to me i want you all to contact her who are having any problem related to marriage issue and relationship problem she will solve it for you. her email is traditionalspellhospital@gmail.com she is a woman and she is great. wish you good time. He cast spells for different purposes like (1) If you want your ex back. (2) if you always have bad dream (3) You want to be promoted in your office. (4) You want women/men to run after you. (5) If you want a child. (6) You want to be rich. (7) You want to tie your husband/wife to be yours forever. (8) If you need financial assistance. (9) HIV/AIDS CURE (10) is the only answer to that your problem of winning the lottery Contact him today on: traditionalspellhospital@gmail.com
See also
With over 3.3 billion people living in areas at risk of malaria transmission and over 3000 of them dying every ... Read more
Tags: malaria , drug , africa
Researchers at Johns Hopkins University have identified a gene which repressed in tumor cells, puts a halt to c... Read more
Tags: medicine , cancer
Cancer experts from Denmark have found an enzyme that seems to induce cancer senescence.... Read more
Tags: cancer , medicine