FDA: 2021 NEW DRUG THERAPY APPROVALS IN ONCOLOGY
2021 marked the 50th anniversary of the National Cancer Act, landmark legislation committed to fighting cancer. In this anniversary year, FDA’s Center for Drug Evaluation and Research (CDER) approved many therapies for different cancers. Four new drugs were approved for non-small cell lung cancer, including one non-small cell lung cancer type previously thought to be resistant to treatment. CDER also approved therapy for some types of basal cell carcinoma, the most common form of skin cancer, for certain patient populations.
The first approved immunotherapy to be used as a first-line treatment for esophageal cancer, gastric cancer, and gastroesophageal junction (GEJ) adenocarcinoma was an important cancer approval for 2021. CDER approved two other therapies for certain patients with HER2-positive gastric cancer and GEJ adenocarcinoma; one of these therapies was also approved for esophageal cancer, advanced kidney cancer, and as an adjuvant treatment for kidney cancer.
With regard to breast cancer, CDER approved therapy for early-stage, triple-negative breast cancer, or cancer that does not respond to hormone therapies or medications that target HER2 protein receptors.
Other CDER approvals for rare cancers include:
1) two treatments for adults with certain kinds of cholangiocarcinoma, a group of aggressive cancers that start in the bile duct;
2) a therapy for adults to treat certain tumors that are associated with von Hippel-Lindau disease, an inherited disorder characterized by tumors and cysts;
3) a therapy to be used together with other treatments for light chain amyloidosis, a condition that interferes with normal organ functions due to abnormal protein build-up; and
4) the first FDA-approved treatment 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.