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  1. 2023 OCE Annual Report

Oncology Regulatory Review 2023

AR Regulatory Review Blue

The OCE collaborates with three FDA product centers reviewing drugs, biologic therapies, and devices to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review. Several of OCE's regulatory programs and projects addressing important topics also provide short annual updates below.

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OCE Regulatory Programs:

Drugs and Biologic Therapies: Office of Oncologic Diseases, CDER

The Office of Oncologic Diseases (OOD) in the Center for Drug Evaluation and Research (CDER) approved 13 novel drugs (new medical entities or biologics) for treatment of various types of cancer including colorectal, prostate, lung and low-grade gliomas. Among the novel drug approvals were three first-in-class entities—drugs with mechanisms of action different from those of existing therapies:

  • Talquetamab-tgvs injection (Talvey) to treat adults with refractory or relapsed multiple myeloma who have received other therapies.
  • Nirogacestat (Ogsiveo) for adults with progressing desmoid tumors who require systemic treatment. This is the first FDA-approved treatment for desmoid tumors.
  • Capivasertib (Truqap) with fulvestrant for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test.

OOD also completed 67 other approval decisions to expand the use or patient population of previously approved drugs. Several therapies were approved for various pediatric and rare cancers (see sections below). OOD clinical reviewers published an article describing the 2023 oncology approvals: Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development (covering approvals from November 8, 2022, to October 6, 2023).

Cellular Cancer Therapies: CBER

The Center for Biologics Evaluation and Research (CBER) reviews and regulates cellular cancer therapies in partnership with OCE. 

In 2023, CBER and OCE approved one new cellular therapy product for hematologic malignancy in 2023, omidubicel-only (OMISIRGE). The product is approved to reduce the time to neutrophil recovery and the incidence of infection in adults and children receiving umbilical cord blood transplants following myeloablative conditioning as treatment for hematologic malignancies. CBER and OCE also approved an efficacy supplement for axicabtagene ciloleucel (Yescarta), and a safety supplement for brexucabtagene autoleucel (Tecartus).

2023 CDER and CBER Oncology Approvals 

NMEs/Original BLA

  • CDER NDAs 
  • CDER BLAs 
  • CDER Regular Approval
  • CDER Accelerated Approval
  • RTOR
  • AAiD

14 (13 CDER, 1 CBER)

  • 7
  • 6
  • 1
  • 7
  • 6
  • 4
  • 11
Supplements (new indication) 42 (42 CDER, 0 CBER) (2 RTOR, 26 AAid)
Supplements (new population) 9 (9 CDER, 0 CBER) (2 RTOR, 4 AAid)

Supplements (other)

2 (CBER)
505b2 15
Biosimilars 1
Total Approvals 83
  • Breakthrough Designation
  • 11 (10 CDER, 1 CBER)
  • Fast Track
  • 7 (7 CDER, 0 CBER)
  • Priority Review
  • 48 (47 CDER, 1 CBER)

AAid: Assessment Aid; BLA: Biologics License Application; NME: new molecular entity; RTOR: Real-Time Oncology Review.

Oncology Devices: CDRH

The Center for Devices and Radiological Health (CDRH) reviews and regulates oncology devices, including in vitro diagnostics (IVDs), in partnership with OCE. In 2023 CDRH in collaboration with OCE authorized 118 oncology devices including 61 IVDs, with 26 IVDs having new indications and of those 15 having new companion diagnostic indications. Additionally, 41 radiation oncology and diagnostic imaging devices were authorized as well as other oncology devices including: breast cancer sentinel lymph node identification, tumor ablation, biopsy, soft tissue markers, and orthopedic devices. Some of the pre-market submission highlights include:

  • Invitae Common Hereditary Cancers Panel De Novo, the first authorization for a qualitative high-throughput sequencing based in vitro diagnostic test system intended for analysis of germline human genomic DNA extracted from whole blood for detection of substitutions, small insertion and deletion alterations, and copy number variants in a panel of targeted genes. This test system is intended to provide information for use by qualified health care professionals, in accordance with professional guidelines, for hereditary cancer predisposition assessment and to aid in identifying hereditary genetic variants potentially associated with a diagnosed cancer.
  • Over the counter 23andMe Personal Genome Service Cancer Predisposition Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) to expand the number of BRCA1/2 variants detected to 44 and cleared a predetermined change control plan to add more BRCA1/BRCA2 variants without the need for additional premarket review.
  • EasySep Human Bone Marrow CD138 Positive Selection Kit intended to enrich CD138+ cells from bone marrow collected from patients diagnosed with multiple myeloma.
  • Bladder EpiCheck Kit, which detects a novel biomarker for bladder cancer monitoring. The kit is intended for the qualitative detection of DNA methylation patterns of 15 loci in human DNA (from urine specimens) that are associated with transitional cell carcinoma of the bladder. It is indicated for use as a non-invasive method to monitor for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with non-muscle invasive bladder cancer.
  • Idylla MSI Test, an IVD that detects a novel microsatellite instability biomarker. The text detects seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) and is indicated for the qualitative identification of microsatellite instability in colorectal cancer tumors, indicative of mismatch repair deficiency, and as an aid in the identification of probable Lynch syndrome to help identify patients that would benefit from additional genetic testing to diagnose Lynch syndrome.
  • BRAHMS CgA II Kryptor an IVD to measure Chromogranin A in human serum and used as an aid in monitoring of disease progression in patients with gastroentero-pancreatic neuroendocrine tumors (GEP-NETs, grade 1 and grade 2).
  • Elecsys Tg II an IVD to measure Thyroglobulin to use an aid in monitoring for the presence of persistent or recurrent/metastatic disease in patients who have differentiated thyroid cancer and have had thyroid surgery (with or without ablative therapy).
  • RefleXion Medical Radiotherapy System, a combination linear accelerator and positron emission tomography system that can treat targets in lung and bone using biology-guided radiation therapy.
  • P-Cure Proton Beam Therapy System, a new proton system that can deliver a proton beam to targets in the head, neck, and thorax in patients that are in a seated position.
  • HistoSonics Edison System for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound. This is a novel ablation method that generates cavitation and differs from high-intensity focused ultrasounds which uses heat to destroy tissue.

In March 2023, FDA issued two safety communication updates, UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants, sharing information from the FDA's review of literature and medical device reports about SCC in the capsule around breast implants. FDA informed health care providers that they can now submit case reports of SCC, various lymphomas, and any other cancers in the capsule around breast implants to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE).

CDRH held an advisory panel meeting on November 29 on the design of multi-cancer detection (MCD) in vitro diagnostic devices as well as potential study designs and study outcomes of interest that could inform the assessment of the probable benefits and risks of MCD screening tests. The committee’s discussion and recommendations from this meeting will help inform future Agency regulatory efforts for these novel tests.



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