Inotuzumab ozogamicin
RN: 635715-01-4
UNII: P93RUU11P7

Pfizer Inc., Oncology Institute Of Southern Switzerland  INNOVATOR

http://chem.sis.nlm.nih.gov/chemidplus/rn/635715-01-4

• MF 1680.6764
• Oncological Treatment

FDA grants breakthrough status for Pfizer’s leukaemia drug inotuzumab ozogamicin
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Pfizer’s investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin to treat acute lymphoblastic leukaemia (ALL).

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Pfizer’s investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin to treat acute lymphoblastic leukaemia (ALL).

The breakthrough status was based on data from the Phase III INO-VATE ALL trial, which enrolled 326 adult patients with relapsed or refractory CD22-positive ALL and compared inotuzumab ozogamicin to standard of care chemotherapy………….http://www.pharmaceutical-technology.com/news/newsfda-grants-breakthrough-status-pfizer-leukaemia-drug-inotuzumab-ozogamicin-4697877?WT.mc_id=DN_News

EVER SINCE POST WAS WRITTEN…..FGD APPROVAL Inotuzumab ozogamicin

PFIZER

LINK….https://newdrugapprovals.org/2015/10/23/fda-grants-breakthrough-status-for-pfizers-leukaemia-drug-inotuzumab-ozogamicin/

Inotuzumab ozogamicin (CMC-544) is an antibody-drug conjugate for the treatment of cancers.^[1] It consists of the humanized monoclonal antibody inotuzumab (for CD22), linked to a cytotoxic agent from the class of calicheamicins (which is reflected by ‘ozogamicin‘ in the drug’s name).^[2]

This drug is being developed by Pfizer and UCB.

It is undergoing numerous clinical trials,^[3] including two phase II trials for Non-Hodgkin lymphoma (NHL).

A phase III trial in patients with follicular b-cell NHL has been terminated due to poor enrollment.^[4] A Phase III trial in patients with relapsed or refractory CD22+ aggressive non-Hodgkin lymphoma (NHL) who were not candidates for intensive high-dose chemotherapy was terminated for futility.^[5]

Monoclonal antibodies (mAbs) and derivatives are currently the fastest growing class of therapeutic molecules. More than 30 G-type immunoglobulins (IgG) and related agents have been approved over the past 25 years mainly for cancers and inflammatory diseases. In oncology, mAbs are often combined with cytotoxic drugs to enhance their therapeutic efficacy. Alternatively, small anti-neoplastic molecules can be chemically conjugated to mAbs, used both as carriers (increased half-life) and as targeting agents (selectivity). Potential benefits of antibody-drug conjugates (ADCs), strategies, and development challenges are discussed in this review. Several examples of ADCs are presented with emphasis on three major molecules currently in late clinical development as well as next generation thio-mAbs conjugates with improved therapeutic index.

PATENT

http://www.google.com/patents/WO2013088304A1?cl=en

Inotuzumab ozogamicin:

is described in U.S. Patent Application No. 10/428894

U.S. Patent Application No. 10/428894

References

1.  Statement On A Nonproprietary Name Adopted By The Usan Council – Inotuzumab ozogamicin, American Medical Association.
2.  Takeshita, A; Shinjo, K; Yamakage, N; Ono, T; Hirano, I; Matsui, H; Shigeno, K; Nakamura, S; Tobita, T; Maekawa, M (2009). “CMC-544 (inotuzumab ozogamicin) shows less effect on multidrug resistant cells: analyses in cell lines and cells from patients with B-cell chronic lymphocytic leukaemia and lymphoma.”. British journal of haematology 146 (1): 34–43.doi:10.1111/j.1365-2141.2009.07701.x. PMID 19388933.
3.  http://clinicaltrials.gov/ct2/results?term=Inotuzumab+ozogamicin
4.  http://clinicaltrials.gov/ct2/show/NCT00562965
5.  http://pfizer.newshq.businesswire.com/press-release/pfizer-discontinues-phase-3-study-inotuzumab-ozogamicin-relapsed-or-refractory-aggress
6. http://pubs.rsc.org/en/content/articlelanding/2008/np/b514294f#!divAbstract

Structure of inotuzumab ozogamicin. ABOVE

Inotuzumab ozogamicin^?

Monoclonal antibody
Type	Whole antibody
Source	Humanized (from mouse)
Target	CD22
Identifiers
CAS Registry Number	635715-01-4
ATC code	None
UNII	P93RUU11P7
KEGG	D08933
Chemical data
Formula	C6518H10002N1738O2036S42
Molecular mass	150,000 Daltons

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