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Inside the Black Box

CNS Cancers

Approval of Dinutuximab for High-Risk Neuroblastoma: Lessons Learned in Expediting the Development of Pediatric Cancer Drugs

The ASCO Post  / December 10, 2016

On March 10, 2015, the U.S. Food and Drug Administration (FDA) granted regular approval to dinutuximab (formerly known as chimeric 14.18 antibody; Unituxin) for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (retino...

Health-Care Policy

Oncology Drug Approvals: Year in Review

Richard Pazdur, MD  / February 25, 2016

In 2015, the Office of Hematology and Oncology Products (OHOP) approved 16 new molecular entities. The most notable were drug approvals in disease areas such as non–small cell lung cancer, colorectal cancer, breast cancer, melanoma, renal cancer, and diseases that are particularly difficult to tre...

Issues in Oncology

FDA’s Pregnancy Category Labeling

Todd Palmby, PhD, and Eias Zahalka, PhD, MBA  / July 25, 2015

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA supervisory toxicologist Todd Palmby, PhD, and pharmacologist Eias Zahalka, PhD, MBA, discuss the approach taken in the Office of ...

Issues in Oncology

Development and Approval of Biosimilar Products

Leah Christl, PhD, and Albert Deisseroth, MD, PhD  / March 25, 2015

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, Leah Christl, PhD, and Albert Deisseroth, MD, PhD, answer questions about biosimilar products. Dr. Christl is the Associate Director f...

Issues in Oncology

Pharmacokinetics and Exposure Response in Drug Development

Julie Bullock, PharmD, and Nitin Mehrotra, PhD  / February 25, 2015

INSIDE THE BLACK BOX is an occasional column offering insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, former clinical pharmacology team leader Julie Bullock, PharmD, and current team leader Nitin Mehrotra, PhD, discuss how pharmacokineti...

Issues in Oncology

Top 10 Myths About FDA’s Office of Hematology and Oncology Products

Gideon Blumenthal, MD, and Tatiana Prowell, MD  / January 25, 2015

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Gideon Blumenthal, MD, and Tatiana Prowell, MD, discuss 10 common myths about FDA’s Office of Hematology and Oncology ...

Hematologic Malignancies
Solid Tumors
Issues in Oncology

Top 10 Myths About FDA’s Office of Hematology and Oncology Products

Gideon Blumenthal, MD, and Tatiana Prowell, MD  / November 15, 2014

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Gideon Blumenthal, MD, and Tatiana Prowell, MD, discuss 10 common myths about FDA’s Office of Hematology and Oncology ...

Issues in Oncology

Patient-Reported Outcomes in Hematology and Oncology Product Development

The ASCO Post  / September 15, 2014

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, Virginia Kwitkowski, MS, RN, ACNP-BC, and Elektra Papadopoulos, MD, MPH, discuss FDA’s current approach to the review of study endpoin...

Lung Cancer

FDA Approval of Ceritinib for the Treatment of ALK-Positive Non–Small Cell Lung Cancer

The ASCO Post  / August 15, 2014

INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Sean Khozin, MD, MPH, and Dikran Kazandjian, MD, discuss anaplastic lymphoma kinase (ALK)-positive non–small cell lung...

Hematologic Malignancies

FDA Approval of Siltuximab for Multicentric Castleman’s Disease

The ASCO Post  / June 25, 2014

INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, FDA hematologist/oncologist Albert Deisseroth, MD, PhD, discusses the recent approval of siltuximab for patients with multicentric Castleman’s disease who are human immun...

Issues in Oncology

Cancer Chemotherapy Use During Pregnancy

The ASCO Post  / May 15, 2014

INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, National Toxicology Program scientists Kembra L. Howdeshell, PhD, and Michael D. Shelby, PhD, discuss a recently completed monograph that reviews the published data on pr...

Health-Care Policy

The FDA’s Bad Ad Program

The ASCO Post  / April 15, 2014

INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, Robert Dean, MBA, Director, and Michael Sauers, Deputy Director, of Division II in the FDA’s Office of Prescription Drug Promotion discuss the FDA’s Bad Ad program. The ...

Lung Cancer

Molecularly Targeted Therapy for Lung Cancer

The ASCO Post  / January 15, 2014

INSIDE THE BLACK BOX is an occasional column offering insight into the FDA and its policies and procedures. This installment addresses a changing paradigm in the treatment of lung cancer, exemplified by concurrent approval of a companion diagnostic with each of several new targeted agents or new dru...

Breast Cancer

Neoadjuvant Treatment of Early Breast Cancer

The ASCO Post  / November 15, 2013

INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this first installment, FDA Clinical Reviewers Laleh Amiri-Kordestani, MD, and Suparna Wedam, MD, discuss FDA’s recent approval of pertuzumab (Perjeta) for the neoadjuvant treatment of HER...

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