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Chugai files Herceptin for post surgical Adjuvant treatment of HER2+ve breast cancer in Japan



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Trastuzumab, monoclonal antibody

Thursday, 7 February 2013

Chugai has filed an NDA based on evidence in the public domain with Japan MHLW seeking approval for the additional dosage and administration of once a week  Herceptin for post surgical adjuvant  administration in breast cancer that over express HER2.
In Japan, Herceptinis currently marketed for the indications of “breast cancer that overexpresses HER2,” and “advanced or recurrent gastric cancer over expressing HER2, not amenable to curative resection.
The filing was made based on the decision at the meeting of the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council, held on January 31, 2013, which confirmed that filing through the “NDA based on evidence in the public domain” was reasonable for this additional dosage and administration.

Trastuzumab (INN; trade names HerclonHerceptin) is a monoclonal antibody that interferes with the HER2/neu receptor. Its main use is to treat certain breast cancers.

The HER receptors are proteins that are embedded in the cell membrane and communicate molecular signals from outside the cell (molecules called EGFs) to inside the cell, and turn genes on and off. The HER proteins stimulate cell proliferation. In some cancers, notably certain types of breast cancer, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably.[1]

The original studies of trastuzumab showed that it improved overall survival in late-stage (metastatic) breast cancer from 20.3 to 25.1 months,[1] but there is controversy over whether trastuzumab is effective in earlier stage cancer.[2]Trastuzumab is also controversial because of its cost, as much as $100,000 per year,[3] and while certain private insurance companies in the U.S. and government health care systems in Canada, England and elsewhere have refused to pay for trastuzumab for certain patients, some companies have since accepted trastuzumab treatment as a covered preventative treatment.[4]

Trastuzumab is also being studied for the treatment of other cancers.[5] It has been used with some success in women with uterine papillary serous carcinomas that overexpress HER2/neu.[6]


  1. Hudis, CA (2007). “Trastuzumab–mechanism of action and use in clinical practice”. N Engl J Med. 357 (1): 39–51.doi:10.1056/NEJMra043186PMID 17611206Jul 5;357(1):39-51. Review /article
  2. 129 Herceptin and early breast cancer: a moment for caution [Editorial]. Lancet 2005;366:1673.
  3. “Herceptin or Trastuzumab: Efficacy, Side Effects”. Health and Life.
  4. “At last, Axa pays for Herceptin”. 2006.
  5. Vecchione L. Novel investigational drugs for gastric cancer.Expert Opin Investig Drugs. 2009 May 26. [Epub ahead of publication]. Review /article.
  6. Santin AD, Bellone S, Roman JJ, McKenney JK, Pecorelli S. (2008). “Trastuzumab treatment in patients with advanced or recurrent endometrial carcinoma overexpressing HER2/neu”.Int J Gynaecol Obstet 102 (2): 128–31.doi:10.1016/j.ijgo.2008.04.008PMID 18555254.

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DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with AFRICURE PHARMA, ROW2TECH, NIPER-G, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 32 PLUS year tenure till date Feb 2023, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 38 lakh plus views on New Drug Approvals Blog in 227 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc He has total of 32 International and Indian awards

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