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  1. 2021 OCE Annual Report

Oncology Regulatory Review

OCE AR 2021 Regulatory Review

Highlights of 2021

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.


The Office of Oncologic Diseases (OOD) in the Center for Drug Evaluation and Research (CDER) approved four new drugs for non-small lung cancer (Tepmetko, Rybrevant, Lumakras, Exkivity), including one non-small cell lung cancer type previously thought to be resistant to treatment. 

For skin cancer, OOD approved a therapy (Libtayo) for some types of basal cell carcinoma, the most common form of `skin cancer, for certain patient populations. 

OOD also approved the first immunotherapy (Opdivo), or therapy that stimulates or suppresses the immune system, as a first-line treatment for esophageal (esophagus-related) cancer, gastric (stomach) cancer, and gastroesophageal junction (GEJ) adenocarcinoma, a rare cancer that starts where the esophagus and stomach join together. Also related to stomach and esophageal cancer, OOD approved two other therapies (Enhertu and Keytruda) for certain patients with HER2-positive gastric cancer and GEJ adenocarcinoma, one of which (Keytruda) also was approved for esophageal cancer, advanced kidney cancer, and as an add-on treatment for kidney cancer. 

Additionally, OOD approved Keytruda for early-stage, triple negative breast cancer, or cancer that does not respond to hormonal therapies or medications that target HER2 protein receptors. 

Other approvals for rare cancers included:

  • Two treatments (Truseltiq and Tibsovo) for adults with certain kinds of cholangiocarcinoma, a group of aggressive cancers that start in the bile duct.
  • A therapy (Welireg) for use in adults to treat certain tumors that are associated with von Hippel-Lindau disease an inherited disorder characterized by tumors and cysts. 
  • A therapy (Darzalex Faspro) to be used together with other treatments for light chain amyloidosis, a cancer occurring when an abnormal protein builds up in the organs. 
  • A treatment (Fyarro) for locally advanced unresectable or metastatic perivascular epithelioid cell tumor (PEComa), a group of rare tumors that form in the soft tissues of the stomach, intestines, lungs and other body parts. This is the first FDA-approved treatment for PEComa. 


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

In 2021, CBER and OCE approved a new biologic therapy, Abecma (idecabtagene vicleucel) for adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Also, a new indication was granted for Tecartus (brexucabtagene autoleucel) for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Tecartus was previously approved for treatment of adults with relapsed or refractory mantle cell lymphoma.

In addition, FDA granted accelerated approval to Yescarta (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

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


The Center for Devices and Radiological Health (CDRH) reviews and regulates oncology devices and diagnostics in partnership with OCE. During 2021, CDRH and OCE authorized 16 oncology-related in vitro diagnostic devices (IVDs) including 12 companion diagnostic approvals. 

Eight companion diagnostic devices were approved in areas of unmet need such as for the treatment of cholangiocarcinoma and to detect KRAS G12C variants in patients with non-small cell lung cancer. The first tumor agnostic immunohistochemistry companion diagnostic was authorized for the identification of patients with solid tumors that are DNA mismatch repair deficient. In addition, a second group labeling claim was approved, for patients with unresectable or metastatic melanoma to detect specific BRAF variants for the selection of BRAF inhibitors or BRAF/MEK inhibitor combinations.

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

2021 Oncology Approvals*

NMEs/ Original BLA 16 (6 Regular, 12 AA)**  (9 RTOR) (6 AAid)
Supplements (new indication) 50 (43 Regular, 7 AA) (16 RTOR) (26 AAid)
Supplements (new population) 8
505b2 6
In vitro diagnostic devices (PMAs) 16 (12 companion diagnostics)
Breakthrough Designation 25 (22 CDER, 3 CBER)
Breakthrough Device Designation 13
Fast Track 58
Priority Review 70 (68 CDER, 2 CBER)

*Approval numbers reflect approvals from CBER, CDER and CDRH

** The number of regular and accelerated approvals is greater than the total number of NMEs because some NME applications are administratively split due to different actions for different indications within the NME.

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

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