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|October 17, 2016 2:00 a.m.|
|Teva Receives Positive Opinion from European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to Extend Indication of Trisenox® for First Line Treatment of Low- to Intermediate Risk Acute Promyelocytic Leukemia (APL)|
APL is a life-threatening type of leukemia as it can cause
uncontrollable bleeding and can kill within hours or days if left
Commenting on the announcement,
The CHMP positive opinion is a formal recommendation to grant marketing
authorization for an extended indication for first line treatment for
Trisenox®. The recommendation will now be reviewed by the
In commenting on the CHMP positive opinion, Rob Koremans, President &
CEO, Teva Global Specialty Medicines said, “As a company committed to
providing medicines and solutions that really make a difference in
patients’ lives, we’re pleased to reach this important milestone, and
hope soon to be able to offer a chemotherapy-free treatment regimen for
APL patients at the point of diagnosis. Recognizing the high unmet
patient need in this orphan disease, we’ve put everything in place to
obtain the label extension for this life-saving treatment. We look
forward to receiving an approval from the
About Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia is a form of acute myeloid leukemia (AML), a cancer of the blood-forming tissue (bone marrow). Approximately 10% to 15% of patients initially diagnosed with AML present with the aggressive sub-type of the condition, APL.
In normal bone marrow, hematopoietic stem cells produce red blood cells (erythrocytes) that carry oxygen, white blood cells (leukocytes) that protect the body from infection, and platelets (thrombocytes) that are involved in blood clotting. In APL, immature white blood cells called promyelocytes accumulate in the bone marrow. The overgrowth of promyelocytes leads to a shortage of normal white and red blood cells and platelets in the body, which causes many of the signs and symptoms of the condition.
People with APL are especially susceptible to developing bruises, small red dots under the skin (petechiae), nosebleeds, bleeding from the gums, blood in the urine (hematuria), or excessive menstrual bleeding. The abnormal bleeding and bruising occur because substances are released that cause excessive blood clotting, and as a consequence lead to a low number of platelets in the blood (thrombocytopenia). The low number of red blood cells (anemia) can cause people with acute promyelocytic leukemia to have pale skin (pallor) or excessive tiredness (fatigue). In addition, affected individuals may heal slowly from injuries or have frequent infections due to the decrease of normal white blood cells that fight infection. Furthermore, the leukemic cells can expand into the bones and joints, which may cause pain in those areas. Other general signs and symptoms may occur as well, such as fever, loss of appetite, and weight loss.
APL is generally diagnosed in much younger patients than in AML (the median age is approximately 40 for APL patients and 70 for AML patients), and can be diagnosed in patients of any age.
The marketing approval for Trisenox® was granted based on results from a multicenter study in which 40 relapsed APL patients were treated with Trisenox® 0.15 mg/kg until bone marrow remission or a maximum of 60 days. Thirty-four patients (85 percent) achieved complete remission after two cycles. When the results for these 40 patients were combined with those for the 12 patients in a pilot trial, an overall response rate of 87 percent was observed.
1mL of Trisenox® contains 1mg of arsenic trioxide. Trisenox® is a concentrate for solution for infusion. It is a sterile, clear, colorless, aqueous solution. Trisenox® must be administered under the supervision of a physician who is experienced in the management of acute leukaemias, and special monitoring procedures must be followed.
The APL0406 Intergroup GIMEMA-AMLSG-SAL study was a prospective,
randomized, multicenter, open-label, phase III non-inferiority study.
Eligible patients were adults between 18 and 71 years of age with newly
diagnosed, genetically proven low- or intermediate-risk APL (WBC at
diagnosis ≤ 103 x 109/L). Overall, 276 patients were randomly assigned
to receive ATRA-ATO or ATRA-CHT between
Post-induction events included two relapses and one death in CR in the ATRA-ATO arm and two instances of molecular resistance after third consolidation, 15 relapses, and five deaths in CR in the ATRA-CHT arm. Two patients in the ATRA-CHT arm developed a therapy-related myeloid neoplasm.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our specialty products, especially Copaxone®
(which faces competition from orally-administered alternatives and a
generic version); our ability to integrate
Teva Pharmaceutical Industries Ltd.