Welcome to Cancer-Forums.net!   

Advertisments:



Useful Links:

American Cancer Society
National Cancer Institute
Cancer Definition

What Is The Blood Cancer Drug Jakavi?

The latest news from Cancer Trials and Cancer Research around the world.

What Is The Blood Cancer Drug Jakavi?

Postby rhys45 » Sat Oct 07, 2017 7:24 am

(PR)JAKAVI® the first medication to receive Health Canada approval to treat patients with myelofibrosis

? Myelofibrosis is a life-threatening blood cancer associated with progressive, debilitating symptoms that can severely impact quality of life and shorten survival

? PRJAKAVI® (ruxolitinib tablets) approval is based on results from the most extensive myelofibrosis clinical trial program to-date

DORVAL, QC, July 5, 2012 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) has received approval from Health Canada for JAKAVI (ruxolitinib tablets), a drug for the treatment of disease-related splenomegaly (enlarged spleen) and/or its associated symptoms in adult patients with myelofibrosis (MF), a blood cancer.1 JAKAVI is the first antineoplastic agent indicated for this patient population.

Given the unmet medical need in this area, the JAKAVI submission was reviewed under a priority review status by Health Canada. JAKAVI represents the only approved JAK 1 and JAK 2 inhibitor for the treatment of splenomegaly and/or its associated symptoms in adult patients with MF in Canada. Until now, there have been no Health Canada approved treatments for these patients.

"JAKAVI offers an option to patients who suffer from myelofibrosis. It can improve some of the more serious and debilitating complications of this disease by shrinking their enlarged spleen," says Dr. Vikas Gupta, Associate Professor and Clinical Investigator, Leukemia Program at Princess Margaret Cancer Centre, Toronto. "Day-to-day living improves: patients become more active, their pain diminishes, sleep improves and they regain their appetite, which allows for an improved quality of life."

Myelofibrosis is a rare, life-threatening blood cancer affecting the bone marrow and is characterized by bone marrow scarring (fibrosis), an enlarged spleen (splenomegaly) and debilitating consequences, including fatigue, fever, night sweats, itchy skin, bone pain, abdominal pain or discomfort, and weight loss.2,3 Prognosis for patients with MF is poor, with a median survival of approximately five-to-six years, and limited treatment options.4,5,6

"We applaud Health Canada's rapid approval of this important treatment and we look forward to a timely, positive recommendation from the panCanandian Oncology Drug Review so JAKAVI can be available to all Canadians with myelofibrosis," says Durhane Wong-Rieger, President of the Canadian Organization for Rare Disorders.

Largest Clinical Program in MF

Health Canada's approval of JAKAVI is based on results from the largest clinical program conducted in MF called COMFORT (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy),7,8 with Canadian centres in Vancouver, London, Toronto, Ottawa, Montreal, and St. John's (NFLD).

The New England Journal of Medicine recently published results from two Phase III trials which found that treatment with Janus kinase (JAK) inhibitor - JAKAVI, reduced disease burden in patients with MF. 9,10 In the first Phase III trial, results from COMFORT-I show JAKAVI provides statistically significant clinical improvement in patients with MF at just 24 weeks as measured by spleen volume reduction and symptom improvement compared to placebo.11 Results were first presented at the 47th American Society of Clinical Oncology (ASCO) annual meeting in June 2011.12

In the second Phase III trial, COMFORT-II, data show JAKAVI provides marked and durable clinical improvement in patients with MF, measured by reduction in spleen volume at 48 weeks and 24 weeks compared to best available therapy.13

JAKAVI is available in three strengths: 5 mg, 15 mg and 20 mg tablets taken orally twice daily. For the dosage and administration of JAKAVI, please refer to the approved JAKAVI Product Monograph dated June 15, 2012.

About JAKAVI

JAKAVI offers a unique mechanism of action that targets what studies suggest is the underlying pathology of the disease, rather than using medications developed for treatment of other conditions that have limited effectiveness. A potent and selective dual oral JAK 1 and JAK 2 inhibitor, JAKAVI is designed to specifically inhibit the biological activity of these JAK enzymes for the treatment of this patient population with MF.

JAKAVI is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. The overall safety profile of JAKAVI is consistent across all clinical studies.24,25 JAKAVI was generally well-tolerated with manageable and predictable side effects.26,27,28 The most frequently reported hematological adverse reactions (any CTCAE; grade N=301 patients from ruxolitinib arms of COMFORT-I and COMFORT-II) included reversible thrombocytopenia (69.8%) (an abnormal drop in the number of blood cells involved in forming blood clots), anemia (82.4%) (the condition of having less than the normal amount of red blood cells or hemoglobin in the blood) and neutropenia (15.6%) (an abnormally low level of neutrophils in the blood.
rhys45
 
Posts: 1055
Joined: Fri Apr 01, 2011 5:28 pm

What Is The Blood Cancer Drug Jakavi?

Postby Cyneric » Sat Oct 07, 2017 7:30 am

There is a drug called Lyrica that treats neuropathy. I don't know what drugs he can take with his condition, but ask his doctor about Lyrica. I have a form of Neuropathy and I take Lyrica. It has helped me a lot. A drug called Neurontin is also used to treat neuropathy, as well as some anti-depressants.
Cyneric
 
Posts: 55
Joined: Thu Jan 02, 2014 8:18 pm


Return to Cancer News and Clinical Trials

 


  • Related topics
    Replies
    Views
    Last post