Oncology Regulatory Review 2024
The Oncology Center of Excellence 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.
Jump to:
- Drugs and Biologic Therapies: CDER
- Cellular Cancer Therapies: CBER
- 2024 Oncology Approvals Table
- Oncology Devices: CDRH
Drugs and Biologic Therapies: Office of Oncologic Diseases
In 2024, the Office of Oncologic Diseases (OOD) in the Center for Drug Evaluation and Research (CDER) approved 16 novel drugs (new medical entities or biologics) for treatment of various types of cancer including gynecologic, genitourinary, lung, gastrointestinal, breast, thyroid, leukemia, lymphoma, and myelodysplastic syndromes.
OOD also completed 29 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 2024 oncology approvals: FDA Cancer Therapy Approvals in 2024: New Options for Patients Across Cancer Types and Therapeutic Classes.
Cellular and Gene Therapies
The Center for Biologics Evaluation and Research (CBER) reviews and regulates cellular cancer therapies in partnership with OCE. In 2024, CBER and OCE approved two new cellular therapy products: lifileucel (Amtagvi) and afamitresgene autoleucel (Tecelra).
CBER and OCE also approved an efficacy supplement for axicabtagene ciloleucel (Yescarta), and a safety supplement for brexucabtagene autoleucel (Tecartus).
CDER and CBER 2024 Oncology Approvals
NMEs or Orginial BLA
| 16 CDER, 2 CBER
|
New indication to already approved drug
| 29 CDER, 2 CBER
|
AAid: Assessment Aid; BLA: Biologics License Application; NME: new molecular entity; RTOR: Real-Time Oncology Review. RTOR + AAID exceed the total approval numbers because AAID can include RTOR.
Oncology Devices
In 2024, the Center for Devices and Radiological Health (CDRH) in collaboration with OCE authorized 76 oncology devices. These include 27 in vitro diagnostic devices (IVDs), four of which were new IVDs with a total of eleven companion diagnostic claims, and nine expanded companion diagnostic indications for six previously authorized IVDs. Forty radiation oncology and diagnostic imaging devices were authorized as well as nine other oncology-related devices.
Pre-market submission highlights include:
- FDA approval of Agilent Technologies’ MAGE-A4 IHC 1F9 pharmDx, a companion diagnostic for identifying patients with synovial sarcoma who could benefit from Tecelra (afamitresgene autoleucel), the first FDA-approved T cell receptor (TCR) gene therapy.
- Approval of two new NGS-based tumor profiling assays with CDx claims including MI Cancer Seek with seven companion diagnostic indications and TruSight Oncology Comprehensive with two companion diagnostic indications.
- Approval to expand the intended use of FoundationOne CDx (F1CDx) with four additional companion diagnostic claims, three of which were combination treatments.
- Approval to expand the intended use of Oncomine Dx Target Test, as a companion diagnostic for VORANIGO (vorasidenib)– the first approval by the FDA of a systemic therapy for patients with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.
- Approval of three colorectal cancer (CRC) screening IVDs including Guardant Shield, a blood based colorectal IVD that has the potential to increase colorectal cancer screening rates through higher patient adherence and screening compliance.
- De novo authorization granted for Elio Plasma Focus Dx Liquid, a high throughput sequencing based tumor profiling test of circulating cell-free nucleic acid.
- Clearance of several digital pathology devices such as whole slide imager (WSI) scanning systems, interoperable viewing software and displays. Notably, these include the Leica Aperio GT 450DX, the first test system with the DICOM image format which facilitates interoperability between the components of a WSI test system.
- Approval of multiple updates to Optune Gio, a device indicated for the treatment of patients with glioblastoma. Updates include new software used to configure or optimize the Optune transducer array layout that incorporates the patient’s own imaging data, as well as new HFE transducer arrays.
- Clearance of the cCeLL – In vivo, an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues. The cCeLL – In vivo utilizes near infared (NIR) confocal endomicroscopy with indocyanine green fluorescence to visualize brain tissues, including tumor cells.
- Approval of Lumicell Direct Visualization System, a breakthrough-designated fluorescence imaging device used with pegulicianine for intraoperative detection of cancerous tissue within the resection cavity during breast cancer surgery.
- De Novo authorization of DermaSensor, a breakthrough-designated elastic scattering spectroscopy device with AI software for adjunctive diagnosis of malignant skin lesions (melanoma, squamous cell carcinoma, basal cell carcinoma).
- Clearance of several software applications with Artificial Intelligence/Machine Learning-based algorithms, including treatment planning systems and secondary check software, as well as several automated contouring software applications to aid radiation oncologists in contouring both organs at risk and tumors to expedite the clinical workflow.
- Clearance of multiple patient tracking, positioning systems, and devices to alter radiation doses to the skin.
CDRH issued a communication in February 2024 encouraging scientific and transparent public dialogue concerning breast implant safety and effectiveness, and continued evaluation of all available information about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and other breast implant related illnesses.