WILMINGTON, Del.--(BUSINESS WIRE)--
Incyte Corporation (INCY) announced today that the U.S. Food and Drug Administration (FDA) has updated prescribing information for Jakafi (ruxolitinib) to include new recommended dosing guidance for patients with low platelet counts and additional safety information. Approved in November 2011, Jakafi is the first and only FDA-approved product for the treatment of patients with intermediate or high-risk myelofibrosis.
The prescribing information for Jakafi now includes a new recommended starting dose of 5 mg twice daily of Jakafi for patients with baseline platelet counts between 50100 x 109/L (50,000 to 100,000) and the flexibility for subsequent dose modifications based on safety and efficacy. The FDA decision to expand the dosing information followed a review of the supplemental New Drug Application (sNDA), which included data from an ongoing Phase II trial (Study 258) of patients with baseline platelet counts of 50,000 to 100,000. In this trial, the starting dose of 5 mg twice daily could be adjusted up or down based on protocol defined hematology criteria with a target dose of 10 mg twice daily to achieve clinical response. The safety and efficacy findings from the current interim analysis of Study 258 are generally consistent with the results observed in the pivotal, phase III COMFORT-I and COMFORT-II program.
The expanded dosing guidance provides physicians with important new information intended to help patients with low platelet counts experience the clinical benefits of Jakafi, including meaningful spleen reduction and symptom improvement, stated Paul Friedman, M.D., Incytes President and Chief Executive Officer.
Additionally, new safety information has been added to the Warnings and Precautions section of the prescribing information stating: Progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate.
Language has also been added to the Patient Counseling Information section advising healthcare professionals to inform patients regarding the early signs and symptoms of PML.
These changes to the prescribing information are based on one known case of PML with an undetermined relationship to ruxolitinib in the approximately 9,800 myelofibrosis patients treated with ruxolitinib worldwide in clinical trials or with commercial product.There are reports in the medical literature to suggest that patients with myeloproliferative neoplasms, including myelofibrosis, may be at higher risk of developing PML1-4.
The newly revised Prescribing Information is available at http://www.incyte.com.
About Jakafi
Jakafi is a prescription medicine used to treat people with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States.
Read this article:
Jakafi® (ruxolitinib) Prescribing Information Updated with Expanded Dosing Guidance and New Safety Information
- ACT - Stem Cell Trial for AMD and Stargardt - Phase 1 - September 15th, 2011 [September 15th, 2011]
- Excerpt from: "The Urban Wire" Internet Radio Podcast: FDA Oks embryonic stem cell trials for humans - September 15th, 2011 [September 15th, 2011]
- Advanced Cell Technology (ACT) AMD stem cell clinical phase - September 15th, 2011 [September 15th, 2011]
- Stem Cells Retina and cornea regeneration ACT Dr lanza - Advanced Cell Technology - September 15th, 2011 [September 15th, 2011]
- Spinal Patient Receives Stem Cells in First Experimental Treatment - September 15th, 2011 [September 15th, 2011]
- Bloomberg: Geron, StemCells Rise 4% - September 15th, 2011 [September 15th, 2011]
- Bringing Stem Cell Cures to the Clinic: UC Davis GMP Facility - September 15th, 2011 [September 15th, 2011]
- Researchers in California Show Results for Spinal Cord Injuries Using Embryonic Stem Cells - September 15th, 2011 [September 15th, 2011]
- Bill Caldwell, Chairman - September 20th, 2011 [September 20th, 2011]
- Advanced Cell Technology OneMedForum 2011 - September 20th, 2011 [September 20th, 2011]
- ACT edmund vision stem cells program Advanced Cell Technology - September 20th, 2011 [September 20th, 2011]
- Texans for Stem Cell Research Learn for Life: KXAN Coverage Aired August 16th, 2011 - September 20th, 2011 [September 20th, 2011]
- ACT - Dr Lanza - Hermangioblast program - Advanced cell technology - September 23rd, 2011 [September 23rd, 2011]
- Anticipating the Next Decade of the Genome - Francis Collins, Director of NIH - September 24th, 2011 [September 24th, 2011]
- New Epilepsy Treatment Under Study For Seizures - Part 1 - September 24th, 2011 [September 24th, 2011]
- A Thank You For Trevor Raborn - September 24th, 2011 [September 24th, 2011]
- CBLI Breaking News - September 24th, 2011 [September 24th, 2011]
- What is Cord Blood Banking? The Medical Potential of Newborn Stem Cells - September 24th, 2011 [September 24th, 2011]
- Stem cell medical breakthrough? - September 24th, 2011 [September 24th, 2011]
- NIST Colloquium Series: Next Generation Neural Implants - September 24th, 2011 [September 24th, 2011]
- Alan Lewis: Embryonic Stem Cell Therapies for diabetes - September 24th, 2011 [September 24th, 2011]
- 2011 Predictions for Hair Transplant Developments | Arocha Hair Restoration - September 24th, 2011 [September 24th, 2011]
- Healthbeat - Stem Cell Research - September 24th, 2011 [September 24th, 2011]
- Living With ALS - September 24th, 2011 [September 24th, 2011]
- A Revolutionary New Potential Treatment for Glioblastoma... - September 24th, 2011 [September 24th, 2011]
- Lyme Disease: Challenges and Innovations - September 24th, 2011 [September 24th, 2011]
- 2010: Cord blood saving lives [CNN: 5-30-2011] - September 24th, 2011 [September 24th, 2011]
- Biotechnology, Diagnostics, and Genomics: Panel Discussion - September 24th, 2011 [September 24th, 2011]
- Pharmacogenomics - September 24th, 2011 [September 24th, 2011]
- Brickheads - Osteobots Practice Skit.mpg - September 24th, 2011 [September 24th, 2011]
- A veteran lives with ALS - September 26th, 2011 [September 26th, 2011]
- Healthy Body = Functional Body. Hollywood Look Side Effect: Healthy Function - September 26th, 2011 [September 26th, 2011]
- 2009 Flu Summit: Opening Remarks - September 26th, 2011 [September 26th, 2011]
- Cord Blood Breakthrough - September 28th, 2011 [September 28th, 2011]
- SENS5 - Leucocyte transfusions as a novel immunotherapy for cancer patients - October 2nd, 2011 [October 2nd, 2011]
- Lymphoma Drug SGN-35 - The Nebraska Medical Center - October 2nd, 2011 [October 2nd, 2011]
- ACell Hair Restoration with Dr. Gary Hitzig and Dr. Amiya Prasad - Video - October 14th, 2011 [October 14th, 2011]
- Hans Keirstead: Developing therapies based on embryonic stem cells - Video - October 14th, 2011 [October 14th, 2011]
- NJN News Healthwatch Report - Cornea Treatment Study - Video - October 20th, 2011 [October 20th, 2011]
- HIV/AIDS may be prevented by new lubricant - Video - October 22nd, 2011 [October 22nd, 2011]
- MFIII Switzerland PE Sheep Placenta Glandular therapy Study - Client Interviews - Video - October 22nd, 2011 [October 22nd, 2011]
- Love Diabetes: BCG and Noncompliant Patients - Video - October 25th, 2011 [October 25th, 2011]
- Dr. Alimorad Farshchian statement on embryonic stem cells - Video - October 27th, 2011 [October 27th, 2011]
- StemCellTV Daily Report-October 29, 2011 - Video - October 30th, 2011 [October 30th, 2011]
- Stephen McKenna MD - 8 - Video - October 31st, 2011 [October 31st, 2011]
- ALS Stem Cell Trial at Emory - Video - November 22nd, 2011 [November 22nd, 2011]
- Target Product Profile: Ellen Feigal - 2011 CIRM Grantee Meeting - Video - December 6th, 2011 [December 6th, 2011]
- Monoclonal Antibodies: Stanford Academia-Industry Collaboration - Video - December 8th, 2011 [December 8th, 2011]
- Parkinson's Disease Guidelines (Part 2) - Video - December 9th, 2011 [December 9th, 2011]
- Macular Degeneration Drugs - Video - December 13th, 2011 [December 13th, 2011]
- BrainStorm Cell Therapeutics (OTCBB:BCLI) Has Potentially Developed A Treatment For ALS - January 31st, 2012 [January 31st, 2012]
- StemCells, Inc. Receives FDA Authorization for Age-Related Macular Degeneration Clinical Trial - February 3rd, 2012 [February 3rd, 2012]
- Stemedica Cell Technologies - Documentary - Video - February 4th, 2012 [February 4th, 2012]
- (GMCR, STEM, DSCO) CRWENewswire.com Stocks In Action - Video - February 7th, 2012 [February 7th, 2012]
- Bioheart Acquires Exclusive Rights to Ageless Regenerative Institute's Adipose Cell Technology - February 14th, 2012 [February 14th, 2012]
- Neuralstem Announces Closing of $5.2-Million Registered Direct Offering - February 14th, 2012 [February 14th, 2012]
- Scientists Repair Heart Attack Damage Using Patient's Own Stem Cells To Regrow Healthy Heart Muscle - February 14th, 2012 [February 14th, 2012]
- Stem Cells Regrow Healthy Heart Muscle In Heart Attack Patients - February 15th, 2012 [February 15th, 2012]
- Groundbreaking Clinical Trials Study Cord Blood Stem Cells to Help Treat Brain Injury and Hearing Loss - February 17th, 2012 [February 17th, 2012]
- Novelos Therapeutics Announces Enrollment of First Patient in Lung Cancer Trial With I-124-CLR1404 (Light) Cancer ... - February 22nd, 2012 [February 22nd, 2012]
- IntelliCell BioScience Inc. Procedure Enables Norwegian Star Basketball Player to Fully Recover from Patella ... - February 22nd, 2012 [February 22nd, 2012]
- The Lancet Publishes Results from Gentium's Phase III Defibrotide Trial for the Prevention of VOD in Paediatric Patients - February 27th, 2012 [February 27th, 2012]
- Bioheart Issues Shareholder Letter Announcing Progress and New Initiatives - March 1st, 2012 [March 1st, 2012]
- Bioheart Issues Shareholder Letter Announcing Progress - March 1st, 2012 [March 1st, 2012]
- Novelos Therapeutics and Academic Collaborators Have Three Abstracts Accepted for Presentation at 2012 AACR Annual ... - March 1st, 2012 [March 1st, 2012]
- Marshall Edwards Submits Investigational New Drug Application for Oncology Drug Candidate ME-344 - March 6th, 2012 [March 6th, 2012]
- Will StemCells Walk The Talk? - March 7th, 2012 [March 7th, 2012]
- Internationally Recognized Leukemia Physician and Researcher to Lead Sylvester Comprehensive Cancer Center - March 7th, 2012 [March 7th, 2012]
- Criminal investigation after patient dies at office of doctor linked to stem cell - March 9th, 2012 [March 9th, 2012]
- Novelos Therapeutics Announces Enrollment of First Patient in Brain Cancer Trial with I-124-CLR1404 (LIGHT) Cancer ... - March 15th, 2012 [March 15th, 2012]
- Vitro Biopharma Receives Approval for Presentation to the International Society for Cellular Therapy - March 20th, 2012 [March 20th, 2012]
- Looking for Innovative Small-Cap Biotech Companies: George Zavoico - March 26th, 2012 [March 26th, 2012]
- Seattle Genetics Announces Pivotal ADCETRIS™ (Brentuximab Vedotin) Hodgkin Lymphoma Study Published in Journal of ... - March 27th, 2012 [March 27th, 2012]
- Gentium Reports Fourth Quarter and Year End 2011 Financial Results - March 28th, 2012 [March 28th, 2012]
- Basketball’s influence on stem cell treatments in sports medicine - March 30th, 2012 [March 30th, 2012]
- Cardium Announces U.S. Market Introduction of Excellagen™ - March 31st, 2012 [March 31st, 2012]
- Optimer Pharmaceuticals, Inc. Announces Presentation at ECCMID of Post-Hoc Subgroup Analysis of DIFICID in Adult ... - March 31st, 2012 [March 31st, 2012]
- New Data Demonstrates DIFICLIR™ May Offer Benefits for Cancer Patients, who are at High Risk of Clostridium Difficile ... - April 1st, 2012 [April 1st, 2012]
- SynGen Inc. Receives $5 million Equity Investment from Bay City Capital, LLC - April 19th, 2012 [April 19th, 2012]
- Gene Ray, Founder of $2.6 Billion Titan Corp, Invests in Medistem's ERC Technology and Joins Advisory Board - April 26th, 2012 [April 26th, 2012]