24-Month FDA Post Marketing Commitment Completed
JERUSALEM--(BUSINESS WIRE)--Feb. 13, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced
that the U.S. Food and Drug Administration (FDA) has granted full
approval of SYNRIBO® (omacetaxine mepesuccinate) for
injection. This oncology portfolio product received an accelerated
approval in October, 2012 with additional clinical trial data required
to fulfill post marketing requirements set forth by the FDA.
SYNRIBO is indicated for adult patients with chronic phase (CP) or
accelerated phase (AP) chronic myeloid leukemia (CML) with resistance
and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).
“With this approval, based on the final analysis of two Phase II trials
that evaluated efficacy and tolerability data of SYNRIBO®, we
believe healthcare providers can be even more confident in the clinical
profile of this important medicine,” said Rob Koremans, M.D., President
and CEO, Global Specialty Medicines. “This approval reinforces our
ongoing commitment to providing SYNRIBO® to people living
with CML who have failed two or more TKI therapies.“
Indication
SYNRIBO® is indicated for the treatment of adult patients
with chronic or accelerated phase chronic myeloid leukemia (CML) with
resistance and/or intolerance to two or more tyrosine kinase inhibitors
(TKI).
Important Safety Information
Warnings and Precautions
-
Myelosuppression: Patients with chronic phase and accelerated phase
CML who used SYNRIBO® experienced severe and fatal
myelosuppression including thrombocytopenia, neutropenia, and anemia.
Patients with neutropenia are at increased risk for infections, and
should be monitored frequently and advised to contact a physician if
they have symptoms of infection or fever. Monitor complete blood
counts weekly during induction and initial maintenance cycles and
every two weeks during later maintenance cycles, as clinically
indicated
-
Bleeding: SYNRIBO® causes severe thrombocytopenia which
increases the risk of hemorrhage. Fatalities from cerebral hemorrhage
have occurred. Severe, non-fatal gastrointestinal hemorrhages have
also occurred. Monitor platelet counts as part of the complete blood
count (CBC) monitoring as recommended. Avoid anticoagulants, aspirin,
and nonsteroidal anti-inflammatory drugs (NSAIDs) when the platelet
count is <50,000/μL as they may increase the risk of bleeding
-
Hyperglycemia: SYNRIBO® can induce glucose intolerance.
Monitor blood glucose levels frequently, especially in patients with
diabetes or risk factors for diabetes. Avoid SYNRIBO® in
patients with poorly controlled diabetes mellitus until good glycemic
control has been established
-
Embryo-fetal toxicity: SYNRIBO® can cause fetal harm when
administered to a pregnant woman. Women should be advised to avoid
becoming pregnant while using SYNRIBO®
Adverse Reactions
-
Serious adverse reactions (frequency ≥5%) in chronic phase patients:
bone marrow failure, thrombocytopenia, febrile neutropenia, and
infections
-
Serious adverse reactions (frequency ≥5%) in accelerated phase
patients: febrile neutropenia, thrombocytopenia, anemia, diarrhea, and
infections
-
Most common adverse reactions (frequency ≥20%) in chronic and
accelerated phase patients: thrombocytopenia, anemia, neutropenia,
diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia,
infection, and lymphopenia
-
You are encouraged to report side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
About CML
Chronic myeloid leukemia (also called chronic myelogenous leukemia) is
one of four main types of leukemia and is a cancer of the blood and bone
marrow. In CML, part of the DNA from chromosome 9 breaks off and trades
places with chromosome 22 during cell division. This results in the
“Philadelphia chromosome,” which is an abnormal chromosome 22 that
contains the BCR-ABL hybrid gene. This hybrid gene leads to
over-production of the enzyme tyrosine kinase in the bone marrow, which
causes too many stem cells to develop into white blood cells
(granulocytes or blasts). The American Cancer Society
estimates that in 2014, there will be 5,980 new cases of CML diagnosed
in the United States, and 810 deaths from the disease. The
prevalence of CML has grown significantly since 2001 after the
introduction of new treatments. It is estimated that the prevalence of
CML in the United States is 26,359, according to the Leukemia & Lymphoma
Society.
About SYNRIBO®
SYNRIBO®, which was originally granted an accelerated
approval by the FDA in October 2012, is the first protein synthesis
inhibitor for CML. While a detailed understanding of how SYNRIBO®
works has not been fully defined, it has been shown to prevent the
production of specific proteins. The proteins affected by SYNRIBO®
are known as Bcr-Abl and Mcl-1, as shown in laboratory studies not
involving patients. These are examples of some of the proteins that are
produced in higher levels by cancerous CML cells and help drive the
disease. As a protein synthesis inhibitor, the way SYNRIBO®
is believed to work does not directly depend on Bcr-Abl binding.
For Full Prescribing Information, click here.
About the Phase 2 Pivotal Studies (202 and 203)
The original approval of SYNRIBO® was based on an analysis of
combined data subsets from two Phase 2, open-label, multicenter studies.
The pooled analysis included patients who had received 2 or more
approved TKIs and, at a minimum, had evidence of resistance or
intolerance to dasatinib and/or nilotinib. 47% of CP patients and 63% of
AP patients had failed treatment with imatinib, dasatinib, and
nilotinib. The majority of patients had also received other treatments
including hydroxyurea, interferon, and cytarabine.
-
For CP patients, 18% (14/76) achieved a major cytogenetic response
(MCyR) with a mean time to MCyR onset of 3.5 months. The median
duration of MCyR for these patients was 12.5 months (Kaplan-Meier
estimate).
-
For AP Patients, 14% (5/35) achieved a major hematologic response
(MaHR) with a mean time to response onset of 2.3 months. The median
duration of MaHR for these patients was 4.7 months (Kaplan-Meier
estimate).
-
Most common adverse reactions (frequency ≥20%) in chronic and
accelerated phase patients: thrombocytopenia, anemia, neutropenia,
diarrhea, nausea, fatigue, asthenia, injection site reaction, pyrexia,
infection, and lymphopenia
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in approximately 60 countries.
Teva's branded businesses focus on CNS, oncology, pain, respiratory and
women's health therapeutic areas as well as biologics. Teva currently
employs approximately 45,000 people around the world and reached $20.3
billion in net revenues in 2013.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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