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eChapter 2020: Goodman & Gilman Year in Review New and Noteworthy FDA Regulatory Actions

Nelda Murri, PharmD, MBA

PART 2: OTHER NOTEWORTHY FDA REGULATORY ACTIONS

Note: The following symbols are used throughout.

! Accelerated approval (final FDA approval is contingent on demonstration of a clinical benefit in a confirmatory trial)

Biologic license designation

$ Breakthrough therapy

# Cancer drug

† Orphan indication

In the first half of 2020, the U.S. Food and Drug Administration (FDA) granted 23 noteworthy new drug application (NDA) licenses and approved 13 noteworthy new biologic license applications (BLAs). Part 1 of this series looked back at first-in-class and “me-too” NDA and BLA approvals, breakthrough ($) therapies, orphan indications (†), cancer drugs (#), and companion diagnostics for precision cancer therapy. The remaining noteworthy FDA accomplishments are compiled in this part of the series, including dosing and other labeling changes approved for established drugs (Table P2-1), approved follow-on products, new combination product introductions, COVID-19 pandemic-related drug actions, market withdrawals, pediatric and pregnancy labeling changes, prescription-to-OTC switches, and other noteworthy FDA regulatory accomplishments related to drug efficacy and safety.

Labeling Changes

Table P2-1Marketed Drugs with Notable Labeling Changes Approved in the First Half of 2020
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Table P2-1 Marketed Drugs with Notable Labeling Changes Approved in the First Half of 2020
Drug Pharmacology Labeling Change Goodman & Gilman’s The Pharmacological Basis of Therapeutics, 13th Edition Reference
Atezolizumab ¶# (TECENTRIQ)1 Programmed death ligand 1 (PD-L1) blocking antibody

  • New use: First line for metastatic non-small cell lung cancer with no EGFR or ALK genomic aberrations and high PD-L1 expression as determined by an FDA-approved test.2

  • Companion test: VENTANA PD-L1(SP142) Assay for high PD-L1 expression NSCLC.3

 Chapter 67. Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules > Atezolizumab
Atezolizumab ¶# (TECENTRIQ)1 in combination with bevacizumab ¶# Programmed death ligand 1 (PD-L1) blocking antibody in combination with vascular endothelial growth factor inhibitor New use: Treatment-naïve, unresectable/metastatic hepatocellular carcinoma.$ †4 Chapter 67. Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules >Atezolizumab; > Bevacizumab
Avelumab ¶# (BAVENCIO)5 Programmed death ligand 1 (PD-L1) blocking antibody New use: Locally advanced/metastatic urothelial carcinoma maintenance treatment that has not progressed with first-line platinum-containing chemotherapy.6 Chapter 67. Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules > Other Anti–PD-L1 Antibodies
Barium 24% (ENTERO VU)7 Radiopaque contrast agent New use: Small bowel radiographic examinations in adults.8 Chapter 50. Gastrointestinal Motility and Water Flux, Emesis, and Biliary and Pancreatic Disease > Miscellaneous Agents for Stimulating Motility
Blinatumomab (BLINCYTO)9 Bispecific CD19-directed CD3 T-cell engager Clarification: Reconstitution and preparation instructions were reworded to improve label comprehension.10 Chapter 67. Pathway-Targeted Therapies: ...

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