DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Farletuzumab
Farletuzumab (MORAb-003) is a monoclonal antibody[1] which is being investigated for the treatment of ovarian cancer.[2][3]
This drug was developed by Morphotek, Inc.
It is targeted at FR-alpha which is overexpressed in some cancers such as ovarian cancer.
USAN FARLETUZUMAB
PRONUNCIATION far” le tooz’ oo mab
THERAPEUTIC CLAIM Treatment of cancer
CHEMICAL NAMES
1. Immunoglobulin G1, anti-(human receptor FR-α (folate receptor α)) (human-mouse monoclonal MORAb-003 heavy chain), disulfide with human-mouse monoclonal MORAb-003 κ-chain, dimer
2. Immunoglobulin G1, anti-(human folate receptor alpha (ovarian tumor-associated antigen Mov18)); humanized mouse monoclonal MORAb-003 γ1 heavy chain (222-217′)-disulfide with humanized mouse monoclonal MORAb-003 κ light chain (228-228”:231-231”)-bisdisulfide dimer
MOLECULAR FORMULA C6466H9928N1716O2020S42
MOLECULAR WEIGHT 145.4 kDa
MANUFACTURER Morphotek, Inc.
CODE DESIGNATION MORAb-003
CAS REGISTRY NUMBER 896723-44-7
Farletuzumab, a humanized monoclonal antibody that targets the folate receptor alpha (FRα), could potentially be used in the treatment of patients with relapsed ovarian cancer, according to the results of a recent open-label phase II trial.Armstrong and colleagues investigated the efficacy of farletuzumab as a single agent or in combination with standard chemotherapy in patients with relapsed ovarian cancer following first-line therapy.
Farletuzumab is a humanized IgG1 monoclonal antibody that targets
the human folate receptor FRα, which is overexpressed in most ovarian
epithelial cancers. It is being developed by Morphotek (now part of
Eisai) for the treatment of ovarian cancer, with regulatory submissions
in 2012.
The pivotal Phase III study in ovarian cancer began
in March 2009; Phase II studies in other indications have since begun.
The 900-patient Phase III study is evaluating two doses of
farletuzumab as an add-on to the standard treatment regimen of
carboplatin and a taxane; this study is completed in
September 2012. A 165-patient study in lung adenocarcinoma began in
December 2010. The initial Phase I study in 25 patients with epithelial
ovarian cancers showed farletuzumab to be well tolerated, with evidence
of efficacy in 36% of the patients (Konner et al. 2010).22
Phase II data from a 54-patient study were presented at the 2008 ASCO meeting, with at least some evidence of efficacy seen in 90% of the treated patients.
Farletuzumab represents one of a number of new treatment options
being developed for the treatment of ovarian cancer, with several other
modalities such as kinase inhibition or PARP inhibition also showing
promise. However, the available evidence suggests that farletuzumab
is likely to represent a significant enhancement in the subset of ovarian
cancer patients at which it has been targeted. If it becomes widely
accepted as a component of the platinum-based treatment regimen, then
it can be expected to be a significant commercial success.
- Statement On A Nonproprietary Name Adopted By The Usan Council – Farletuzumab, American Medical Association.
- ClinicalTrials.gov: Phase II Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
- ClinicalTrials.gov: Phase III Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
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