Farletuzumab ( Eisai) Cancer Review Monoclonal antibody to treat ovarian cancer Farletuzumab (Morphotek, Eisai) is an antifolate receptor alpha mAbs in clinical Phase III trials in ovarian cancer patients. The results of the Phase II trials for advanced ovarian cancer patients not yet published. Interim results indicated durable objective response justifying the need for a Phase III trial. Eisai has provided updated info during the 3Q2010 R&D review of key projects. Farletuzumab is expected to show activity in cancer types which overexpress Folate receptor alpha such as ovarian, breast, colorectal, NSCLC, RCC etc. Phase II study in platinum sensitive ovarian cancer, confirmed extended recurrence period in 21% of patients. The multicentric multinational Phase III study in Pt sensitive ovarian cancer in ongoing and results expected by the end of 2011. BLA/MAA filings planned for 2012. Phase II trials in Pt resistant ovarian cancer and NSCLC are ongoing. New data may be presented during the ASCO 2011 meeting. 
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clinical investigation which have not been approved or reviewed by the
FDA/EMA. Farletuzumab has not been reviewed or approved by the FDA/EMA. The
over expression of folate receptor alpha in ovarian cancer and its
association with aggressive forms of cancer makes this receptor a target
of Farlutuzumab . Fmab (MORAb-003) was discovered and developed by
Morphotek which after its takeover operates as a subsidiary of Eisai. Nomenclature
Farletuzumab is a humanized monoclonal antibody for cancer treatment. The mAbs is in Phase II trials in ovarian cancer patients resistant to platinum drugs. It is Phase III trials in platinum sensitive ovarian cancer patients after their first relapse.  Morphotek Eisai
The company used morphogenics for the following applications. Generated human mAbs bypassing all the patents for recombinant technology. Human Morphodoma Because
of its unique mAbs technology platform and its leads in development,
Morphotek was taken over in 2007 by Eisai for $ 325 million, which by
current prices looks very cheap. The takeover has added
several mAbs to the parent company R&D portfolio and new regulatory
filing and market introductions projected during 2013-2015 period. A
monoclonal antibody MORAb-004 is in Phase 1 trials and targets a cell
surface protein endosialin or tumor endothelial marker 1 TEM and CD248.
MORAb-009 is in Phase II trials for pancreatic cancer and targets cell
surface glycoprotein mesothelin. Farletuzumab is in Phase III trials with orphan drug designation.
There were 21000 new cases of ovarian cancer and 14600 deaths in the US in 2009. There are 65000 new cases worldwide each year. Ovarian Cancer By Pedro [4]  Under Creative Commons Attribution 3.0 License  http://www.nlm.nih.gov/medlineplus/ency/images/ency/fullsize/17106.jpg Under Creative Commons Attribution 3.0 License NCI CDR618030  Estrogen receptor assay NCI Image ID 2028 Cis Platinum Crystals NCI Image ID 2313  Folate Pathway http://sites.huji.ac.il/malaria/maps/folate.gif  FarletuzumabEisai
has provided updated info during the 3Q2010 R&D review of key
projects. Farletuzumab is expected to show activity in cancer types
which overexpress Folate receptor alpha such as ovarian, breast,
colorectal, NSCLC, RCC etc. Phase II study in platinum sensitive ovarian
cancer, confirmed extended recurrence period in 21% of patients. The
multicentric multinational Phase III study in Pt sensitive ovarian
cancer in ongoing and results expected by the end of 2011. BLA/MAA
filings planned for 2012. Phase II trials in Pt resistant ovarian cancer
and NSCLC are ongoing.  ASCO 2010 Abstracts  Abstracts, new data and video presented at ASCO Meeting will be added in this section ASAP #5001-Efficacy
and safety of farletuzumab, a humanized monoclonal antibody to folate
receptor alpha, in platinum-sensitive relapsed ovarian cancer subjects:
Final data from a multicenter phase II study. Allan J. White, MD •
Discussion: Targeting the folate receptor in ovarian cancer. (Please
also note functional folate receptor imaging abstract 44469) Alan Hilary Calvert, MD Phase
II data on 54 patients (pt sensitive after 1st relapse) treated with
weekly injections of farletuzumab (q 21 d for 6 cycles) as a single
agent or added to carboplatin or carboplatin and taxane. After 6 cycles
of dosing, Fmab was given as maintenance dose. No additive toxicity was
observed and Fmab was well tolerated. 44 patients evaluable, 89% of
treated patients had normal CA 125 levels. Nine out of 44 patients had
duration of their second remission lasting longer than the first
remission. Phase
II trial ongoing in 126 ovarian cancer patients resistant to platinum
to be enrolled and randomized in a 2:1 ratio with paclitaxel. The design
of the study and protocol was presented at ASCO meeting. 45A
#5034-Use of 99mTc-EC20 (a folate-targeted imaging agent) to
predict response to therapy with EC145 (folate-targeted therapy) in
advanced ovarian cancer. James Thomas Symanowski Related Cancer Articles
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and its potential rival.   Monoclonal Antibody GuideAcknowledgements
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