Related Experiment Video
Updated: May 24, 2026
09:19
Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
Published on: February 6, 2015
Hurdles in anticancer drug development from a regulatory perspective
1Läkemedelsverket (Medicinal Products Agency), PO Box 26, SE-751 03 Uppsala, Sweden. bertil.jonsson@mpa.se
Nature Reviews. Clinical Oncology
|February 22, 2012
Summary
Anticancer drug development prioritizes speed, often leading to borderline benefit-risk profiles for new cancer therapies. Overcoming hurdles in biomarker-driven development is crucial for improving drug efficacy and patient outcomes.
Area of Science:
- Oncology
- Pharmacology
- Drug Development
Background:
- 48 new anticancer drugs and 77 new indications were approved in the EU between 2001-2012.
- While some drugs offered major improvements (e.g., trastuzumab for breast cancer), many had only borderline favorable benefit-risk balances.
- The principle of 'need for speed' appears to guide anticancer drug development and marketing authorization.
Approach:
- The article assesses advice procedures for marketing authorization of anticancer drugs.
- It discusses challenges and proposes solutions for biomarker-driven drug development.
- The authors examine the balance between rapid drug approval and genuine therapeutic advancement.
Key Points:
- The rapid approval of anticancer drugs may not always align with significant therapeutic gains, especially for drugs with marginal benefits.
- Incentives and streamlined processes are needed to foster development of drugs with truly improved benefit-risk profiles.
- Hurdles within and outside pharmaceutical companies hinder progress in anticancer drug development.
Conclusions:
- The current system may prioritize speed over substantial therapeutic improvement, leading to the approval of drugs with only modest benefits.
- Addressing hurdles in biomarker-driven development is essential for advancing cancer treatment.
- A shift in development strategy is necessary to ensure that new anticancer drugs offer meaningful advantages to patients.
More Related Videos
08:46Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
Published on: December 9, 2015
09:20Preclinical Assessment of the Bioactivity of the Anticancer Coumarin OT48 by Spheroids, Colony Formation Assays, and Zebrafish Xenografts
Published on: June 26, 2018
Related Concept Videos
01:25Drug Regulation
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
01:28Preclinical Development: Overview
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:26Drug Discovery: Overview
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
01:15Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
01:03Drug Control Governance: Regulatory Bodies and Their Impact
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...