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|November 18, 2013 8:05 a.m.|
|Teva Announces Updates to Oncology Biologic Portfolio|
Teva launched LONQUEX® (long-acting G-CSF) in
“Managing the duration of severe neutropenia is critical to optimal
cancer care, because it can disrupt the delivery of cancer treatments,”
“Teva is committed to commercializing G-CSFs globally and is continuing to build the portfolio of short- and long-acting G-CSFs in this important, patient-focused category of medicines,” said Rob Koremans, M.D., President and CEO of Teva Global Specialty Medicines. “By making these treatment options available to physicians and their patients, our goal is to make a meaningful difference in the lives of those with cancer.”
Last week, the company withdrew its balugrastim Biologics License
Application (BLA) from the
Neutropenia is a hematological disorder characterized by an abnormally low number of neutrophils. A person with severe neutropenia has an absolute neutrophil count that is less than 500 mm2 and has a high risk of infection. Neutrophils usually make up 40-60 percent of circulating white blood cells and serve as the primary defense against infections by destroying bacteria in the blood. When chemotherapy agents attack cancer cells in the body, neutrophils and other cells are also attacked. This results in a decrease in healthy white blood cells, making it harder for the body to fight infections. Patients receiving chemotherapy are at risk of becoming neutropenic and can become susceptible to infections that may become life-threatening.
G-CSF is a naturally occurring hormone that is produced by the body to stimulate the bone marrow to produce neutrophils, a type of white blood cell that helps the immune system fight infection. A recombinant form of G-CSF is used to treat certain cancer patients with neutropenia in order to stimulate the bone marrow to produce more white blood cells.
GRANIX™ is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
The safety of GRANIXTM was evaluated in three Phase 3
clinical trials in patients receiving myelosuppressive chemotherapy for
breast cancer, lung cancer, and non-Hodgkin lymphoma (
Important Safety Information
You are encouraged to report side effects of prescription drugs to the
Please click here to view the Full Prescribing Information for GRANIX.
About Lonquex® (lipegfilgrastim)
Lonquex® is a new long-acting recombinant granulocyte
colony-stimulating factor (G-CSF) treatment granted approval by the
Human G-CSF (filgrastim) is a polypeptide that regulates the production and release of functional neutrophils from the bone marrow. Lonquex® is a glycoPEGylated, long-acting form of recombinant human filgrastim, classified with a unique Anatomical Therapeutic Chemical (ATC) Classification System code, with a sustained duration of action due to decreased renal clearance.
The efficacy and tolerability of Lonquex® has been assessed in a full clinical development program. Phase I PK and PD studies in healthy volunteers demonstrate a marked increase in blood neutrophil counts within 24 hours of administration, as well as an increase in the antibacterial activities of neutrophils.
In a pivotal Phase III active-controlled study in 202 patients with stage II-IV breast cancer receiving up to four cycles of chemotherapy consisting of doxorubicin and docetaxel, patients were randomized 1:1 to receive 6 mg Lonquex® or 6 mg pegfilgrastim. The study met the primary efficacy endpoint, DSN in the first cycle of chemotherapy, demonstrating non-inferiority of 6 mg Lonquex® to 6 mg pegfilgrastim (p=0.126), with a comparable tolerability profile. (DSN was calculated as the sum of all days after CTX with ANC <0.5 x 109/L.) Secondary endpoints were favorable for Lonquex®, including an overall mean faster time of 1.5 days to Absolute Neutrophil Count (ANC) recovery of in cycle 1, a trend that was maintained up to cycle 3 (ATP population). (ANC recovery defined as a return of ANC to ≥ 2.0x109/L.)
A second Phase III study in 375 patients at low risk of febrile neutropenia (FN 10-20%) with non-small cell lung cancer was undertaken, comparing 6 mg Lonquex® (n=250) with placebo (n=125). The primary endpoint, incidence of FN in the first cycle of chemotherapy, did not reach statistical significance (p=0.1151). FN is defined as an ANC count of <0.5×109/L with fever (oral body temperature >38.5°C on ≥2 consecutive measurements ≥60 minutes apart.) Secondary endpoint analyses showed a positive trend in favor of Lonquex® vs placebo: duration and incidence of severe neutropenia in cycle 1 was consistently shorter (mean 2.3 ± 2.5 days; p<0.0001) and lower (32.1% vs 59.2%; p<0.0001) in the lipegfilgrastim group overall (mean 0.6 ± 1.1 days) compared with the placebo group. (SN defined as grade 4 neutropenia with an ANC <0.5 x 109/L.) Although incidence of death at study end was 7.2 % (placebo) and 12.5 % (6 mg lipegfilgrastim), the overall incidence of death at the 360-day follow-up was similar between placebo and lipegfilgrastim (44.8 % and 44.0 %, respectively; safety population).
The tolerability of lipegfilgrastim has been evaluated based on results from clinical studies including 506 patients and 76 healthy volunteers treated at least once with lipegfilgrastim. The most common adverse reactions (≥ 1/100 to < 1/10) included: thrombocytopenia, hypokaleamia, headache, erythema and chest pain, with musculoskeletal pains listed as very common (≥ 1/10).
One 6 mg dose of Lonquex® (a single pre-filled syringe) is recommended for adults for each chemotherapy cycle, given approximately 24 hours after cytotoxic chemotherapy.
Lonquex® treatment should be initiated and supervised by
physicians experienced in oncology or haematology. Please consult the
This medicinal product is subject to additional monitoring which will allow Teva to quickly identify new safety information. Healthcare professionals are encouraged to report any suspected adverse reactions to PatientSafety@tevapharm.com
Balugrastim is a once per cycle leukocyte growth factor. The proposed indication is to decrease the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements 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, including
our ability to develop, manufacture, market and sell biopharmaceutical
products, competition for our innovative medicines, especially Copaxone®
(including competition from innovative orally-administered alternatives,
as well as from potential purported generic equivalents), competition
for our generic products (including from other pharmaceutical companies
and as a result of increased governmental pricing pressures),
competition for our specialty pharmaceutical businesses, our ability to
achieve expected results through our specialty, including innovative,
R&D efforts, the effectiveness of our patents and other protections for
innovative products, decreasing opportunities to obtain U.S. market
exclusivity for significant new generic products, our ability to
identify, consummate and successfully integrate acquisitions and license
products, our ability to reduce operating expenses to the extent and
during the timeframe intended by our cost restructuring program,
uncertainties relating to the replacement of and transition to a new
President & Chief Executive Officer, the effects of increased leverage
as a result of recent acquisitions, the extent to which any
manufacturing or quality control problems damage our reputation for high
quality production and require costly remediation, our potential
exposure to product liability claims to the extent not covered by
insurance, increased government scrutiny in both the U.S. and