Top FDA Approvals of 2022

There were some monumental FDA approvals in the cancer space during 2022 — here’s a roundup of our most-read agency decisions of the year.

In the world of cancer care, there are dozens more Food and Drug Administration (FDA)-approved therapies at the end of the year 2022 than there were at the start of the year.

CURE® looked back at the most influential and most-read FDA approvals of the year, from a new classification for patients with breast cancer to an immunotherapy drug for children and adults with a rare type of sarcoma.

Enhertu for HER2-low metastatic breast cancer

In August, the FDA approved Enhertu (fam-trastuzumab-deruxtecan-nxki) for patients with unresectable or metastatic HER2-low breast cancer, establishing a new disease classification for breast cancer — HER2 low — and offering a new targeted agent for this patient population.

Avastin Biosimilar to treat six diseases

Vegzelma (bevacizumab-adcd), a biosimilar for Avastin, was granted FDA approval for six different cancer types: recurrent or metastatic non-squamous non-small cell lung cancer; metastatic colorectal cancer; metastatic renal cell carcinoma recurrent; epithelial ovarian, fallopian tube or primary peritoneal cancer; and persistent, recurrent or metastatic cervical cancer.

Tecentriq for rare sarcoma subtype in adults and children

This month, the FDA approved the immunotherapy agent, Tecentriq (atezolizumab), for adults and children with unresectable or metastatic alveolar soft part sarcoma, a rare disease that is commonly diagnosed in young adults.

Imfinzi-containing regimen for biliary tract cancer

A three-drug regimen consisting of Imfinzi (durvalumab) plus gemcitabine and cisplatin was approved for patients with locally advanced or metastatic biliary tract cancer, after the therapy improved survival compared to standard of care.

Kymriah for relapsed/refractory follicular lymphoma

Kymriah (tisagenlecleucel), a CAR-T cell therapy, was approved for patients with pretreated, relapsed/refractory follicular lymphoma, offering this patient population a long-lasting option for improved survival, according to an expert.


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