Oncology therapies shifted from chemotherapy to molecularly targeted agents and finally to
the era of immune-oncology agents. In contrast to cytotoxic agents, molecularly targeted …

Project Optimus is a US Food and Drug Administration Oncology Center of Excellence
initiative aimed at reforming the dose selection and optimization paradigm in oncology drug …

Historically, dose selection of anticancer drugs has mainly been based on establishing the
maximum tolerated dose in phase 1 clinical trials with a traditional 3 plus 3 design. In the era …

Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor designed to
overcome mechanisms of resistance associated with crizotinib, is approved for the treatment …

The optimal dose for targeted oncology therapeutics is often not the maximum tolerated
dose. Pharmacokinetic/pharmacodynamic (PK/PD) modeling can be an effective tool to …

Xevinapant, an oral inhibitor of apoptosis protein (IAP) inhibitor, demonstrated efficacy in
combination with chemoradiotherapy in a randomized phase II study (NCT02022098) in …

Combination therapies are often evaluated during the clinical development of oncology
investigational agents. A new investigational agent may be combined with one or more …

Abstract Exposure‐response (E‐R) analyses are an integral component of understanding
the benefit/risk profile of novel oncology therapeutics. These analyses are typically …

Simple Summary The majority of oncology drugs approved by the Food and Drug
Administration over the past quarter century have been targeted therapies, designed to act …

The landscape of oncology drug development has witnessed remarkable advancements
over the last few decades, significantly improving clinical outcomes and quality of life for …