The European Commission has granted marketing authorization for Teva Pharmaceutical Industries' Lonquex (lipegfilgrastim). This approval provides the regulatory framework for the commercialization of Lonquex in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein.
Lonquex is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF) with the active ingredient lipegfilgrastim – a novel glycoPEGylated (PEG; polyethylene glycol) filgrastim molecule. Lonquex (lipegfilgrastim) is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Lonquex is intended as a once-per-cycle fixed dose, subcutaneous injection for neutrophil support in cancer patients receiving myelosuppresive chemotherapy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
“This is an important milestone for Teva Specialty Medicines in Europe and demonstrates our commitment to making a difference to the lives of those with cancer” said Dr. Rob Koremans, president and CEO of Teva Specialty Medicines. “Lonquex is an alternative G-CSF treatment for helping manage neutropenia during myelosuppressive chemotherapy. The European approval comes earlier than expected, just 8 weeks after the positive CHMP opinion. We look forward to providing this oncology supportive care treatment option in all European Union member states.”
Lonquex has undergone a full clinical development program, including pre-clinical to clinical in vivo studies, as part of the efficacy and tolerability assessment for use with chemotherapy patients.
Dr Michael Hayden, Teva's president of global R&D and chief scientific officer, commented: “Effective prevention and treatment of febrile neutropenia is an important consideration for clinicians managing cancer patients who are undergoing cytotoxic chemotherapy. As well as targeting cancer cells, chemotherapy affects rapidly-dividing bone marrow cells, thereby dramatically reducing a patient's ability to fight off infection, with potentially serious consequences. This approval is testament to Teva's commitment to bringing new and alternative treatments to market to support clinicians in caring for patients."
Chemotherapy-induced neutropenia (CIN), is a common and potentially life-threatening side–effect of chemotherapy treatment characterized by a decreased level of white blood cells (known as neutrophils). CIN can result in bacterial infections, which can compromise patients’ health. The EORTC Guidelines2 recommend prophylactic G-CSF treatment for chemotherapy patients with an overall high risk (=20%) of developing febrile neutropenia (FN)* to help avoid the risks associated with a low neutrophil count. The side effects of CIN can result in the requirement for chemotherapy dose modifications. Disruption to the treatment schedule can reduce the anti-cancer effects of chemotherapy, which may subsequently affect treatment outcomes.
The marketing authorization of Lonquex (lipegfilgrastim) brings an additional long-acting G-CSF treatment choice to clinicians managing the effects of CIN in patients with cancer in Europe (alongside other currently marketed G-CSFs: short-acting filgrastim and long-acting pegfilgrastim).
Human G-CSF (filgrastim) is a glycoprotein that regulates the production and release of functional neutrophils from the bone marrow. Lonquex (lipegfilgrastim) is a glycoPEGylated, long-acting form of recombinant human filgrastim, classified with a distinct ATC* code, with a sustained duration of action due to decreased renal clearance. Pharmacokinetic effects demonstrate a marked increase in blood neutrophil counts within 24 hours of administration, while increasing the antibacterial activities of neutrophils.1 The efficacy and tolerability of Lonquex has been assessed in a pivotal phase III multinational, multicentre, randomised, double-blind, controlled non-inferiority study. Results demonstrated non-inferiority of Lonquex® to pegfilgrastim (6mg equivalent doses) in chemotherapy-naïve high risk stage II, III or IV breast cancer patients (n=202) receiving doxorubicin/docetaxel chemotherapy, regarding duration of severe neutropenia (DSN) in the first cycle (p=0.126). Secondary efficacy endpoints showed comparable results for Lonquex and pegfilgrastim regarding duration of severe neutropenia (0.9 ± 0.9 vs 0.7 ± 1.0 with Lonquex), incidence of severe neutropenia (51.5% vs 43.6% with Lonquex) and incidence of febrile neutropenia (3% vs 1% with Lonquex) in Cycle 1.1.