Category: Drug Development
The National Cancer Institute’s Clinical Trials Innovation Unit
H&O What is the National Cancer Institute’s (NCI’s) Clinical Trials Innovation Unit (CTIU), why was it established, and what are its goals? MJM The CTIU is […]
New Strategies for Dose Optimization in Oncology: Insights From Targeted Small-Molecule Therapies for Metastatic or Advanced Non–Small Cell Lung Cancer
H&O What types of tyrosine kinase inhibitors are used to treat metastatic or advanced non–small cell lung cancer (NSCLC)? GS There are 2 broad categories of […]
Is the Use of Progression-Free Survival a Valid Endpoint for Trials of Drug Combinations in Oncology?
H&O What are the goals of treatment in cancer, and have they changed over the years? IT The ultimate goals of treatment of any disease are […]
Emerging Targets in Kidney Cancer: Opportunities for Drug Development
H&O How common is kidney cancer? WS Kidney cancer, also known as renal cancer, is an unusual—although perhaps not rare—cancer. There are approximately 76,000 new cases […]
Talking to the FDA About Dose Optimization and the Aims of Project Optimus
H&O What is Project Optimus, and what prompted the creation of this project? MT Project Optimus is a new initiative from the Oncology Center of Excellence […]
Barriers to Adherence to Oral Drug Regimens in Oncology and Strategies for Improvement
H&O How common are oral drugs in oncology? JB Approximately 25% to 35% of the drugs currently used in oncology are administered orally. Most of the […]
Refining Dosing Strategies: Lessons From Singapore’s Health Care System
H&O Could you provide an overview of the health care system in Singapore? BCG The health care system in Singapore is centered on 2 basic tenets. […]
A Patient’s Perspective on Long-Term Toxicities Associated With Cancer Treatment
H&O What are the challenges in measuring long-term toxicities among patients with cancer? PS Many toxicities occur throughout cancer care and cancer treatment. During active treatment, […]
Current and Future Uses of Digital Pathology in Oncology
H&O What is digital pathology? AP Digital pathology entails the digitizing of standard diagnostic pathologic information and decentralization of pathologic review. For example, pathologists may be […]
Chimeric Antigen Receptor T-Cell Therapy Plus Checkpoint Blockade in Thoracic Cancers
H&O How has immunotherapy impacted outcome in thoracic cancers? PA In the past 5 years, knowledge of immunology in thoracic cancers has greatly improved. The results […]
The FDA’s Patient-Focused Drug Development Initiative
H&O What is patient-focused drug development (PFDD)? PK Essentially, PFDD is taking the patient into account throughout the entire drug development process. There are many things […]
Pack-Splitting to Improve Cost-Effectiveness of Oral Agents in Oncology
H&O What is the rationale behind the investigation of alternative dosing strategies of oral agents in oncology? RDH There are 2 key drivers of the […]
Incorporating Preemptive Pharmacogenomic Testing Into the Clinical Setting
H&O What is preemptive pharmacogenomic testing? PO Preemptive pharmacogenomic testing refers to germline genetic testing that is performed before administration of a certain drug to […]
Insights Into Drug Development Using Nanotechnology
H&O What is the objective of your laboratory? JG Overall, the objective is to improve therapy and imaging for patients with cancer through clinically translatable […]
Strategies to Overcome Resistance to PD-1 Inhibitors
H&O How do programmed death 1 (PD-1) inhibitors work? TG There is a growing list of antibodies that target either the PD-1 receptor or the ligand […]
Inclusion of Biopsies in Clinical Trials of Oncology Drugs
H&O What is the role of biopsies in clinical care vs clinical trials? AT The biggest distinction is that in clinical care, a patient will […]
Advances in the Development of Vaccines and Other Immunotherapies for Multiple Myeloma
H&O What types of immune-based therapies are in development for multiple myeloma? DA Immunotherapy is an important area in multiple myeloma, and this field encompasses […]
Targeting the KRAS G12C Mutation in Patients With Advanced Solid Tumors
H&O What is the KRAS G12C mutation? DH RAS mutations are one of the most common mutations in cancer (after the P53 mutation). Estimates suggest […]
How Biosimilars Will Impact Costs and Care in Oncology
H&O How does a biosimilar compare to a biologic therapy or a generic formulation? GL To start, it is necessary to distinguish biologic molecules from […]
A Rational Approach to the Development of Drug Combinations in Thoracic Oncology
H&O What is the typical approach to the development of drug combinations in oncology? DRC In clinical trials, drug combinations can reflect several scenarios. A trial […]