U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Oncology Center of Excellence
  5. OCE Annual Reports
  6. 2022 OCE Annual Report
  7. Oncology Regulatory Review
  1. 2022 OCE Annual Report

Oncology Regulatory Review

OCE 2022 AR Page 3

Highlights of 2022 

The OCE collaborates with the 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.

Drugs and Biologic Therapies (CDER)

The Office of Oncologic Diseases (OOD) in the Center for Drug Evaluation and Research (CDER) approved several new immunotherapeutics and molecularly targeted drugs in 2022 for the treatment of multiple cancer types, including lymphoma, leukemia, multiple myeloma, melanoma, prostate cancer, hepatocellular carcinoma, and cholangiocarcinoma. These included 11 approvals of new drugs or biologic agents, along with 29 labeling expansions. 

The OCE led the development of FDA guidance in 2022, Tissue Agnostic Drug Development in Oncology, and established an Associate Director position to facilitate consistency and policy with respect to tissue agnostic development programs. Notable tissue agnostic approvals included: 

  • Dabrafenib and trametinib for BRAF positive solid tumors.
  • Selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors.

Other notable approvals included:

  • Fam-trastuzumab deruxtecan-nxki, for unresectable or metastatic HER2-low breast cancer. This is the first approved therapy for patients with the HER2-low breast cancer subtype, a newly defined subset of HER2-negative breast cancer.
  • Teclistamab-cqyv for relapsed or refractory multiple myeloma. Tecvayli is the first bispecific therapy directed at both the B-cell maturation antigen protein and cluster of differentiation 3 protein complex and T cell co-receptor.
  • Mosunetuzumab, a bispecific CD20-directed CD3 T-cell engager for relapsed or refractory follicular lymphoma.
  • Mirvetuximab soravtansine-gynx for patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. 
  • Lutetium LU 177 vipivotide tetraxetan, for patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have received at least two specific lines of therapy. Pluvicto is the first PSMA-targeted radiopharmaceutical.
  • Sodium thiosulfate injection to treat ototoxicity associated with cisplatin in pediatric patients.
  • Tebentafusp-tebn for unresectable or metastatic uveal melanoma, a new medical entity (NME) and first approval for this rare cancer.
  • Relatlimab and nivolumab fixed-dose combination, an NME for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
  • Nivolumab in combination with chemotherapy or in combination with ipilimumab for the first-line treatment of esophageal squamous carcinoma.
  • Crizotinib for the treatment of ALK-positive inflammatory myofibroblastic tumors, the first approval for this tumor. 
  • Durvalumab in combination with chemotherapy, the first immunotherapy for the treatment of biliary tract cancer.
  • Futibatinib, an NME for patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements. 
  • Tremelimumab in combination with durvalumab, an NME for the treatment of patients with hepatocellular cancer.

Cellular Cancer Therapies (CBER)

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

In 2022, CBER and OCE approved two original cell therapies and three supplemental indications. 

  • Ciltacabtagene autoleucel (Carvykti), for relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
  • Adofaragene firadenovec (Adstiladrin) for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
  • Axicabtagene ciloleucel (Yescarta), for large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
  • Tisagenlecleucel (Kymriah), granted accelerated approval for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
  • Lisocabtagene maraleucel (Breyanzi) for large B-cell lymphoma (LBCL) refractory to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation due to comorbidities or age.

Visit Oncology (Cancer) / Hematologic Malignancies Approval Notifications for further information on drug and biologics approvals.

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 2022, CDRH in collaboration with OCE authorized 54 oncology-related devices including 18 IVDs, 12 of which were companion diagnostic approvals, 33 radiation oncology and diagnostic imaging, breast cancer sentinel lymph node, and orthopedic devices. Some highlights of these approvals included:

  • Two new tumor agnostic companion diagnostic indications, including the first tumor agnostic next-generation sequencing companion diagnostic for the detection of Microsatellite Instability High status in patients with solid tumors. 
  • A third companion diagnostic group indication for patients with non-small cell lung cancer to detect specific EGFR variants for the selection of tyrosine kinase inhibitors. 
  • The first circulating tumor cell (CTC) enrichment device to enrich CTCs from peripheral blood of cancer patients for subsequent in vitro diagnostic testing. 
  • Computer Aided detection software cleared for identification of prostate and breast cancer, providing diagnostic information such as likelihood of malignancy. 
  • Radiation software planning systems using artificial intelligence and machine learning algorithms, radiation therapy systems including contouring and patient tracking/positioning, as well as MRI-Linear accelerator combination to allow for MRI-image guided radiation therapy. 
  • A novel device-drug combination product using magnetic detection to identify sentinel lymph nodes was approved as part of a sentinel lymph node biopsy procedure in patients with breast cancer undergoing a lumpectomy for peritumoral injection.

In addition, CDRH held a panel meeting to discuss skin lesion analyzer technology and its application to detecting skin cancers in various patient care settings. The Center also issued a safety communication informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. 

Visit Oncology Therapeutic and Diagnostic Devices for further information on CDRH approvals.

2022 Oncology Approvals*

NMEs/Original BLA 12 (4 NDAs CDER, 6 BLAs CDER, 2 BLAs CBER) (5 Regular CDER, 5 AA CDER) (4 RTOR, 11 AAid)
Supplements (new indication) 44 (41 CDER, 3 CBER) (39 Regular, 5 AA) (11 RTOR, 36 AAid)
Supplements (new population) 5
505b2 29
Oncology-Related Devices (total, CDRH)
  • In vitro diagnostic devices (PMAs)
  • Radiation oncology and diagnostic imaging, breast cancer sentinel lymph node, and orthopedic devices
  • 18 (12 companion diagnostics)
  • 33
Breakthrough Designation 17 (13 CDER, 4 CBER)
Breakthrough Device Designation 14 (CDRH)
Fast Track 7 (6 CDER, 1 CBER)
Priority Review 39 (35 CDER, 4 CBER)
*Approval numbers reflect approvals from CBER, CDER and CDRH

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


Back to Top