On December 2, 205 Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, reported that it will present data highlighting its commitment to innovation in blood disorders and hematologic oncology at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, beginning today through Dec. 8, in Orlando, Florida (Press release, Baxalta, DEC 2, 2015, View Source [SID:1234508377]).
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"Our broad presence at ASH (Free ASH Whitepaper) 2015 is a testament to our unwavering commitment to research and our progress in developing new solutions for the hematology and oncology communities," said John Orloff, M.D., head of Research & Development and chief scientific officer, Baxalta. "On the heels of our latest approvals of treatments for hemophilia and leukemia, the data we’re presenting at ASH (Free ASH Whitepaper) further demonstrate the depth and breadth of our clinical programs, and our efforts to improve the lives of patients through valuable therapeutic options."
Advancing Standards in Hemophilia Care with Growing Portfolio
Researchers from Baxalta and its partners will present more than a dozen scientific updates on the company’s leading hemophilia treatments ADVATE [Antihemophilic Factor (Recombinant)] and FEIBA [Anti-Inhibitor Coagulant Complex], newly-approved hemophilia A treatment ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] as well as investigational therapies.
Selected highlights include:
Characteristics of Patients Without Bleeding in a Pivotal Trial of Extended Half-Life, Pegylated, Full-Length Recombinant Factor VIII (BAX 855) in the Treatment of Hemophilia A. Pub # 1105. Session 322: Disorders of Coagulation or Fibrinolysis: Poster II. Saturday, Dec. 5, 5:30 – 7:30 p.m., in Hall A.
Perioperative Efficacy of an Extended Half-Life, Pegylated, Full-Length Recombinant Factor VIII (BAX 855) in Individual Procedures. Pub # 2299. Session 322: Disorders of Coagulation or Fibrinolysis: Poster II. Sunday, Dec. 6, 6 p.m. – 8 p.m., in Hall A.
Pharmacokinetics of a Recombinant Von Willebrand Factor in Patients with Severe Von Willebrand Disease. Pub # 2293. Session 322: Disorders of Coagulation or Fibrinolysis: Poster II. Sunday, Dec. 6, 6 p.m. – 8 p.m., in Hall A.
Adeno-Associated Virus 8 (AAV8) Vector Genome Biodistribution into Body Fluids Following Single Intravenous Administration of BAX 335 Gene Therapy for Hemophilia B. Session 801: Gene Therapy and Transfer: Poster I. Saturday, Dec. 5, 5:30 p.m. – 7:30 p.m., in Hall A.
"The range of hematology data we are presenting at ASH (Free ASH Whitepaper) showcases the real-world value of our differentiated portfolio and our continued focus on driving the future of care for the hemophilia community," said Brian Goff, executive vice president and president, Hematology, Baxalta. "Through our ongoing pursuit of a Bleed-Free World, we are confident that our continued commitment to innovation will contribute to improved care for patients around the world with options that allow them to personalize their treatment plan."
Addressing Unmet Needs in Hematologic Cancers with Late-Stage Pipeline
In addition, the company will showcase data on pacritinib, the company’s investigational treatment for myelofibrosis with partner CTI BioPharma, and ONCASPAR (pegaspargase), the company’s recently acquired treatment for acute lymphoblastic leukemia.
Highlights include:
Analysis of Outcomes by Patient Subgroups in Patients with Myelofibrosis Treated with Pacritinib vs Best Available Therapy (BAT) in the Phase III PERSIST-1 Trial. Session 634: Myeloproliferative Syndromes: Clinical: Early and Late Stage Trials in MPN. Saturday, Dec. 5, at 10:15 a.m., in Room W224.
Pacritinib, a Dual FLT3/JAK2 Inhibitor, Reduces IRAK-1 Signaling in Acute Myeloid Leukemia. Session 616: Acute Myeloid Leukemia: Novel Therapy, Excluding Transplantation: Novel Targeting Approaches. Monday, Dec. 7, at 11:45 a.m., in Room W109.
Relationship Between Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQoL) and Efficacy in Patients with Myelofibrosis in the Phase III PERSIST-1 Trial of Pacritinib Vs. Best Available Therapy (BAT). Session 634: Myeloproliferative Syndromes: Clinical: Poster I. Saturday, Dec. 5, 5:30 p.m. – 7:30 p.m., in Hall A.
"The data presented at ASH (Free ASH Whitepaper) 2015 illustrate our progress in building an innovative, sustainable and diverse portfolio of new oncology treatments," said David Meek, executive vice president and president, Oncology, Baxalta. "We are helping to advance the approach to treating rare and underserved cancers with new innovations and technologies that have the potential to address significant unmet patient needs worldwide."
About ADYNOVATE
ADYNOVATE, [Antihemophilic Factor (Recombinant), PEGylated], is a human antihemophilic factor indicated in adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency) for:
On-demand treatment and control of bleeding episodes
Routine prophylaxis to reduce the frequency of bleeding episodes
ADYNOVATE is not indicated for the treatment of von Willebrand disease.
Detailed Important Risk Information for ADYNOVATE
CONTRAINDICATIONS
ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).
WARNINGS & PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions are possible with ADYNOVATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with other recombinant antihemophilic factor VIII products, including the parent molecule, ADVATE. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.
Neutralizing Antibodies
Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.
ADVERSE REACTIONS
Common adverse reactions (=1% of subjects) reported in the clinical studies were headache and nausea.
For Full Prescribing Information, visit View Source
About ADVATE
ADVATE [Antihemophilic Factor (Recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia A (congenital factor VIII deficiency) for:
Control and prevention of bleeding episodes
Perioperative management
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
ADVATE is not indicated for the treatment of von Willebrand disease.
Detailed Important Risk Information for ADVATE
CONTRAINDICATIONS
ADVATE is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product.
WARNINGS & PRECAUTIONS
Hypersensitivity Reactions
Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. Symptoms include dizziness, paresthesia, rash, flushing, facial swelling, urticaria, dyspnea, pruritus, and vomiting.
Discontinue ADVATE if hypersensitivity symptoms occur and administer appropriate emergency treatment.
Neutralizing Antibodies
Neutralizing antibodies (inhibitors) have been reported following administration of ADVATE predominantly in previously untreated patients (PUPs) and previously minimally treated patients (MTPs). Monitor all patients for the development of factor VIII inhibitors by appropriate clinical observation and laboratory testing. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.
ADVERSE REACTIONS
Serious adverse reactions seen with ADVATE are hypersensitivity reactions, including anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
The most common adverse reactions observed in clinical trials (frequency =5% of subjects) were pyrexia, headache, cough, nasopharyngitis, arthralgia, vomiting, upper respiratory tract infection, limb injury, nasal congestion, and diarrhea.
Please see full prescribing information for ADVATE at: View Source
ADVATE has a demonstrated efficacy and safety profile for the treatment of hemophilia A. ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood-derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is virtually eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII treatments.
ADVATE is the world’s most prescribed FVIII treatment. It is currently approved in 67 countries worldwide, including the United States, Canada, 28 countries in the European Union, Algeria, Argentina, Australia, Brazil, Brunei, Chile, China, Colombia, Ecuador, Hong Kong, Iceland, India, Iraq, Israel, Japan, Kuwait, Macau, Malaysia, Mexico, Morocco, New Zealand, Norway, Panama, Puerto Rico, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, Uruguay, and Venezuela.
About ONCASPAR
ONCASPAR (pegaspargase) is indicated as a component of a multiagent chemotherapeutic regimen for the first–line treatment of patients with acute lymphoblastic leukemia (ALL) and for the treatment of patients with ALL and hypersensitivity to native forms of L-asparaginase.
ONCASPAR is currently approved in the United States as a first line treatment and select European countries as a second line option.
Important Safety Information for ONCASPAR
ONCASPAR is contraindicated in patients with a history of serious allergic reactions to ONCASPAR, and in patients with a history of serious thrombosis, pancreatitis, or serious hemorrhagic events with prior L-asparaginase therapy.
Anaphylaxis or serious allergic reactions can occur; therefore, patients should be observed for one hour after administration. Discontinue ONCASPAR in patients with serious allergic reactions. Patients with abdominal pain should be evaluated for evidence of pancreatitis. Discontinue ONCASPAR in patients with pancreatitis.
ONCASPAR should also be discontinued in patients with serious thrombotic events.
Glucose intolerance, in some cases irreversible, can occur; serum glucose should be monitored. Coagulopathy and hepatotoxicity can occur; appropriate monitoring should be performed.
The most common adverse reactions with ONCASPAR (=2%) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases.
Hyperlipidemia (hypercholesterolemia and hypertriglyceridemia) has been reported in patients exposed to ONCASPAR.
Please click here to review full Product Information: View Source