New Drugs in Oncology

May 31 from 12:30 PM-5:00 PM and June 1 from 7:30 AM-11:00 AM
McCormick Place, Room S100a

Seminar Description

The New Drugs in Oncology Seminar focuses on the theoretical and practical aspects of both recently approved drugs and those on their way to approval. Topics covered include clinical trial design, mechanisms of action, administration, toxicity and side-effect management, and use in the clinic.

Go to to view session slides on your personal device in real time, take notes on slides, pose questions to faculty, and participate in audience polling. Link will be live when the session begins on Thursday, May 31.

Seminar Agenda

Note: Session faculty will be added to the agenda below as presenters are confirmed.

Day 1: Thursday, May 31, 2018: 12:30 PM to 5:00 PM

12:30 PM - 1:00 PM Lunch
1:00 PM - 2:15 PM

Session 1: Tissue Agnostic Drug Development

Shivaani Kummar, MD, FACP—Chair
Stanford University Medical Center


Steven Lemery, MD, MHS
U.S. Food and Drug Administration
Tissue Agnostic Approval—Are They Any Different From Regular Approval?


Keith Flaherty, MD
Massachusetts General Hospital
Tissue Agnostic Drug Development—Operational and Scientific Challenges


George Fisher, MD
Stanford University
MSI- High/MMR-Deficient Cancers as a Tissue-Agnostic Therapeutic Target


David S. Hong, MD
University of Texas MD Anderson Cancer Center
NTRK as a Tissue-Agnostic Therapeutic Target: An Orphan Drug Target


Panel Question and Answer

2:15 PM - 2:30 PM Break
2:30 PM - 3:45 PM

Session 2: Shepherding Cell Based Cancer Therapeutics Toward Approval

Howard L. McLeod, PharmD—Chair
H. Lee Moffitt Cancer Center & Research Institute


Marcela Maus, MD, PhD
Massachusetts General Hospital, Cancer Center
The Academic Experience—Shepherding Development Out of the Labs


Bruce Levine, PhD
Abramson Cancer Center of the University of Pennsylvania
The Difficulties of Getting a New Cell-Based Therapy Into Clinical Development


Terry Fry, MD
Children's Hospital Colorado
The Roadmap of Cell Based Therapies


Najat Bouchkouj, MD
U.S. Food and Drug Administration
Regulatory Challenges Related to Cell-Based Therapies


Panel Question and Answer

3:45 PM - 5:00 PM

Session 3: Continuous Evolution of a Phase I Trial Into An FDA Package

Ashley Ward, MD—Chair
U.S. Food and Drug Administration


Alice T. Shaw, MD, PhD
Massachusetts General Hospital
Lessons Learned From the Rapid Development of ALK Inhibitors


Anthony B. El-Khoueiry, MD
University of Southern California, Norris Comprehensive Cancer Center
Accelerated Approval of Nivolumab in HCC Based on Phase I Subgroup Data


Matt D. Galsky, MD
Icahn School of Medicine at Mount Sinai
Is There A Difference In PD-1/PD-L1 Inhibitors for Urothelial Cancer?


Leigh Marcus, MD
U.S. Food and Drug Administration
FDA Recommendations for Seamless Drug Development


Panel Question and Answer


Day 2: Friday, June 1, 2018: 7:00 AM - 11:00 AM

7:00 AM - 7:30 AM Breakfast
7:30 AM - 8:00 AM

Keynote Lecture: Next Generation Sequencing—Drug Development and Drug Treatment


Roger D. Klein, MD
Cleveland Clinic
The New Era of Drug Development in the Clinic


Panel Question and Answer

8:00 AM - 11:00 AM

Session 4: FDA Approvals and Their Incorporation Into Clinical Practice

George W. Sledge, MD, FASCO​—Chair
Stanford University Medical Center


Elias Jabbour, MD
The University of Texas MD Anderson Cancer Center
Inotuzumab and Gemtuzumab for Acute Leukemia


Eytan Stein, MD
Memorial Sloan Kettering Cancer Center
Enasidenib for Acute Myeloid Leukemia


Panel Question and Answer




Ursula Matulonis, MD
Dana-Farber Cancer Institute
Niraparib for Ovarian Cancer


Karen Reckamp, MD
City of Hope Comprehensive Cancer Center
Brigatinib for Metastatic ALK Positive Non-Small Cell Lung Cancer


Copanlisib for Follicular Lymphoma


Panel Question and Answer

Seminar Committee

View Seminar Committee Disclosures

George W. Sledge, MD, FASCO​ (Co-Chair)​
Stanford University Medical Center

Howard McLeod, PharmD (Co-Chair)​
H. Lee Moffitt Cancer Center and Research Institute

Howard A. Burris, MD, FASCO​
Sarah Cannon Research Institute

Shivaani Kummar, MD, FACP
Stanford University Medical Center

Patricia LoRusso, DO
Yale University

William Sellers, MD
Broad Institute of MIT and Harvard

Anthony W. Tolcher, MD 
The START Center for Cancer Care

Ashley Ward, MD
Food and Drug Administration


 "Jointly Accredited Provider, Interprofessional Continuing Education"

In support of improving patient care, the American Society of Clinical Oncology is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

AMA Credit Designation Statement - Physicians

The American Society of Clinical Oncology Designates this live activity for a maximum of 7.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AAPA/NCCPA Credit Designation Statement - Physician Assistants

Physician Assistants may claim a maximum of 7.0 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society. 

ACPE Credit Designation Statement - Pharmacists

This activity has been approved for 7.0 contact hours (.7 CEUs) under the ACPE universal activity number JA0000152-0000-18-011-L01-P.

Activity type: Knowledge

All non-physician attendees are welcome to submit a request for a Certificate of Participation, which may enable non-physicians to apply their meeting participation toward re-licensure. Please note, however, that all final decisions regarding certificate acceptance will be made by the licensing organization to which the certificate is submitted. 

Target Audience

The 2018 New Drugs in Oncology Seminar is designed for the cancer care team; credit is offered for physicians and pharmacists, but all are encouraged to participate, as they may be able to apply for credit through their own licensing organization.

Learning Objectives

Upon participation in this activity, attendees will be able to:

  • Discuss topics specific to tissue-agnostic drug development to compare and contrast it to tissue-specific drug development
  • Review the development of cell-based therapies and their path to use in the clinic
  • Assess the role of next generation sequencing in drug development and drug treatment
  • Evaluate novel therapeutics and the FDA approval process to review the design of clinical trials

Disclaimer/Unlabeled Usage Statement         

The information presented is that of the contributing authors and does not necessarily represent the views of the American Society of Clinical Oncology and/or any named commercial entity providing financial support. Specific therapies discussed may not be approved and/or specified for use as indicated. Therefore, before prescribing any medication, please review the complete prescribing information including indications, contraindications, warnings, precautions and adverse effects.

Commercial Support

ASCO and Conquer Cancer gratefully awknowledge the following companies for their support of the 2018 New Drugs in Oncology Seminar: