JSCO2016: International Session 12 Pharmacology of Antitumor Agents: New Drug Application (NDA

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The 54th Annual Meeting of Japan Society of Clinical Oncology (JSCO2016)

"Renovation of Cancer Medicine in the Mature Society"



International Session 1: Lung Cancer
International Session 2: Colorectal Cancer
International Session 3: Gastric Cancer
International Session 4: Urological Cancer (Prostate and Renal Cancer)
International Session 5: Supportive Care for Adverse Events
International Session 6: Gynecological Cancer (Uterine Body Cancer and Ovarian Cancer)
International Session 7: Central Nervous System Tumor
International Session 8: New Development of Particle Beam Therapy for Cancer
International Session 9: International Cooperation in Radiation Medicine
International Session 10: Recent Advances In Cancer Immunotherapy
International Session 11: Breast Cancer
International Session 12: Pharmacology of Antitumor Agents: New Drug Application (NDA)
International Session 13: Malignant Lymphoma
International Session 14: Palliative Care
International Session 15: Radiation Therapy
International Session 16: Head and Neck Cancer
International Session 17: Skin Cancer (Malignant Melanoma)
International Session 18: Hepato-Biliary and Pancreas Cancers
International Session 19: Leukemia
International Session 20: Ethics for Clinical Research
International Session 21: Esophageal Cancer
International Session 22: Bone and Soft Tissue Tumor
FACO/JSCO Joint Symposium

Abstract Archives (in Japanese)

International Session 12: Pharmacology of Antitumor Agents: New Drug Application (NDA)


ICH guidelines regarding clinical pharmacology for NDA
Chiyo Imamura (Department of Clinical Pharmacokinetics and Pharmacodynamics, Keio University School of Medicine)
The MHLW publishes scientific guidelines that are harmonised between Japan, Europe and the US by the ICH. The E4, E5 and E15 guidelines address the topics in clinical pharmacology. The assessment of dose-response and consequent dose selection is one of the most important aspects of drug development recognized by ICH E4 "Dose-Response Information to support drug registration". The information of relationships among dose, drug-concentration in blood, and clinical response (efficacy and toxicity), which is the Pharmacokinetics (PK) and Pharmacodynamics (PD) relationships, can provide an appropriate approach to global drug development, by enabling multiple regulatory agencies to make approval decisions from a common database. In global drug development, ethnic differences in PK and PD are critical issues. ICH E5 "Ethnic Factors in the Acceptability of Foreign Clinical Data" classifies intrinsic and extrinsic factors, and describes how to evaluate the PK and PD, and their comparability, in the three major racial groups (Asian, Black, and Caucasian) most relevant to the ICH regions. One of the intrinsic factors is genetic polymorphism of membrane protein transporters and metabolizing enzymes in germ-line mutation, which result in change in PK. The allele frequencies of transporters and enzymes are different among ethnic or racial groups. For example, the frequencies of non-functional and decreased alleles of CYP2C19, CYP2D6 and ABCG2 are higher in Asian than in non-Asian. ICH E15 "Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories" defines key terms in the discipline of pharmacogenomics (PGx) and pharmacogenetics, namely genomic biomarkers, to facilitate their integration into global drug development and approval processes. This is also very useful to develop molecular targeting drugs since the somatic mutation including driver gene mutation has been recognized as the target for precision medicine.


Recently approved drugs and biologics in the United States
Edward C. Li (Department of Pharmacy Practice, University of New England College of Pharmacy, USA)
Last year in the United States, there was a significant amount of new drugs and biologics approved for the treatment of cancer by the US Food and Drug Administration. Targeted therapies continue to be a major focus of new therapies, and many targeted agents are used for more refined and specific genetic mutations within a tumor type. Additionally, immuno-oncology agents such as the PD-1 pathway inhibitors, have dramatically changed the treatment paradigm for a variety of tumor types. At the same time, the United States has struggled to contain the cost of these novel medications, resulting in concerns about patient access to innovative therapies.

This session will review the mechanism of action and therapeutics uses of recently approved drugs and biologics within the United States. The role of immuno-oncology agents will be discussed in context with contemporary treatment guidelines. The session will conclude with an analysis of the challenges related to the cost of cancer medications in the United States.


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