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2022 FDA Drug Approval List, 2022 Biological Approvals and Approved Cellular and Gene Therapy Products

Reporter: Aviva Lev-Ari, PhD, RN

SOURCE

Tal Bahar’s post on LinkedIn on 1/17/2023

Novel Drug Approvals for 2022

FDA’s Center for Drug Evaluation and Research (CDER)

New Molecular Entities (“NMEs”)

• Some of these products have never been used in clinical practice. Below is a listing of new molecular entities and new therapeutic biological products that CDER approved in 2022. This listing does not contain vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products that the Center for Biologics Evaluation and Research approved in 2022. 
• Others are the same as, or related to, previously approved products, and they will compete with those products in the marketplace. See Drugs@FDA for information about all of CDER’s approved drugs and biological products. 

Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that FDA has previously approved. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act. 

Approved Cellular and Gene Therapy Products

Below is a list of licensed products from the Office of Tissues and Advanced Therapies (OTAT).

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Approved Products

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• ABECMA (idecabtagene vicleucel)
  Celgene Corporation, a Bristol-Myers Squibb Company
• ADSTILADRIN
  Ferring Pharmaceuticals A/S
• ALLOCORD (HPC, Cord Blood)
  SSM Cardinal Glennon Children’s Medical Center
• BREYANZI
  Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
• CARVYKTI (ciltacabtagene autoleucel)
  Janssen Biotech, Inc.
• CLEVECORD (HPC Cord Blood)
  Cleveland Cord Blood Center
• Ducord, HPC Cord Blood
  Duke University School of Medicine
• GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)
  Organogenesis Incorporated
• HEMACORD (HPC, cord blood)
  New York Blood Center
• HEMGENIX
  CSL Behring LLC
• HPC, Cord Blood
  Clinimmune Labs, University of Colorado Cord Blood Bank
• HPC, Cord Blood – MD Anderson Cord Blood Bank
  MD Anderson Cord Blood Bank
• HPC, Cord Blood – LifeSouth
  LifeSouth Community Blood Centers, Inc.
• HPC, Cord Blood – Bloodworks
  Bloodworks
• IMLYGIC (talimogene laherparepvec)
  BioVex, Inc., a subsidiary of Amgen Inc.
• KYMRIAH (tisagenlecleucel)
  Novartis Pharmaceuticals Corporation
• LAVIV (Azficel-T)
  Fibrocell Technologies
• LUXTURNA
  Spark Therapeutics, Inc.
• MACI (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane)
  Vericel Corp.
• PROVENGE (sipuleucel-T)
  Dendreon Corp.
• RETHYMIC
  Enzyvant Therapeutics GmbH
• SKYSONA (elivaldogene autotemcel)
  bluebird bio, Inc.
• STRATAGRAFT
  Stratatech Corporation
• TECARTUS (brexucabtagene autoleucel)
  Kite Pharma, Inc.
• YESCARTA (axicabtagene ciloleucel)
  Kite Pharma, Incorporated
• ZYNTEGLO (betibeglogene autotemcel)
  bluebird bio, Inc.
• ZOLGENSMA (onasemnogene abeparvovec-xioi)
  Novartis Gene Therapies, Inc.

Resources For You

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• What Is Gene Therapy? How Does It Work?

SOURCE

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products

There are five FDA-approved CAR-T treatments for blood cancers and two gene therapies to treat rare diseases now on the market in the U.S. The late-stage pipeline could produce several more cancer CAR-Ts and gene therapies to treat a range of diseases.

RELATED: ASH: Bristol Myers’ Breyanzi, Gilead’s Yescarta lock horns in race to move CAR-T therapy to earlier lymphoma

One of the biggest races to watch in the cell therapy space will be that between Gilead Sciences’ Yescarta and Bristol Myers Squibb’s Breyanzi, both of which are gunning to move their CAR-Ts into earlier lines of treatment in large B-cell lymphoma (LBCL). At ASH, both companies rolled out impressive data from their trials in the second-line setting, but Gilead could have the upper hand by virtue of its three-year head start in the market, analysts said. Gilead expects to hear from the FDA on a label expansion in the second-line setting in April.