2018 in Review: New Cancer Drug Approvals

Chemotherapy is one of the most powerful tools we have to treat cancer, and research continues to find new chemotherapy drugs as well as new uses for existing ones. At the same time, newer types of drugs are being developed that work in different ways to attack cancer cells. These types of drugs include targeted therapy, which aims to more precisely identify cancer cells while doing less damage to normal cells, and immunotherapy, which uses the body’s own immune system to help find and destroy cancer.

This year, the US Food and Drug Administration (FDA) granted its second-ever approval for a drug to treat tumors with a specific genetic change regardless of cancer type. And it granted its second-ever approval for a biosimilar drug to treat cancer. A biosimilar is a drug that works a lot like a biological drug that’s already been approved.    

Before any new drug can be sold in the United States, it has to go through an approval process. The FDA evaluates evidence from testing to decide whether the drug’s benefits outweigh any known risks. The FDA also provides doctors and patients with information about how to use the new drug safely.

In 2018, the FDA approved several new drug treatments for different cancer types that American Cancer Society editors believe will make a significant difference.

Adrenal Tumors

Azedra (iobenguane I-131) is a radiotherapy drug that can treat some adults and adolescents ages 12 and older with rare tumors of the adrenal gland called pheochromocytomas, as well as for similar tumors outside of the adrenals, called paragangliomas. 

Breast Cancer

Lynparza (olaparib) was the first drug approved by the FDA specifically for a type of breast cancer caused by a mutated BRCA gene. It’s also the first drug of its kind, known as a PARP inhibitor, approved to treat breast cancer. It’s intended for certain patients whose cancer is HER2-negative.

Talazoparib (Talzenna) was later approved for the same type of breast cancer.

Digestive Tract Cancers

Lutathera (lutetium Lu-177 dotatate) is the first radioactive drug approved to treat people with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). These tumors can occur in the pancreas, stomach, intestines, colon, rectum, or elsewhere in the gastrointestinal tract.

Leukemia

Tibsovo (ivosidenib), a targeted therapy, is the first drug approved to treat acute myeloid leukemia (AML) patients with a specific mutation in the IDH1 gene.

Daurismo (glasdegib) and Venclexta (venetoclax) are also targeted therapies, both approved to treat people newly diagnosed with AML who are not able to undergo intensive chemotherapy.

Gilteritinib (Xospata) was also approved in 2018 for AML.

Lumoxiti (moxetumomab pasudotox-tdfk) is for adults with hairy cell leukemia (HCL) that did not get better with at least 2 different previous treatments or got better but then came back. It’s the first drug of its type, a conjugated monoclonal antibody, to treat HCL.

Lung Cancer

Imfinzi (durvalumab) is part of a newer class of immunotherapy drugs called checkpoint inhibitors. It was approved for people with stage III non-small cell lung cancer whose tumors can’t be removed, and whose cancer has not gotten worse after they received chemotherapy along with radiation.

The FDA in 2018 also approved the targeted drugs Vizimpro (dacomitinib) and Lorbrena (lorlatinib) for non-small cell lung cancer.

Opdivo (nivolumab) was approved for some people with small cell lung cancer. Opdivo was already on the market to treat some types of cancer including non-small cell lung cancer. 

Lymphoma

Truxima (rituximab-abbs) is the first biosimilar drug approved to treat adults with some types of non-Hodgkin lymphoma. A biosimilar is a drug that’s very much like a biological drug that’s already been approved. Truxima is a biosimilar to Rituxan (rituximab), a targeted therapy.

Prostate Cancer

Erleada (apalutamide) was the first FDA-approved treatment for a high-risk type of prostate cancer called non-metastatic castration-resistant prostate cancer.

Xtandi (enzalutamide) was approved for this cancer type soon afterward.

Thyroid Cancer

A 2-drug combination, Tafinlar (dabrafenib) and Mekinist (trametinib), is the first treatment approved by the FDA for anaplastic thyroid cancer, which is an aggressive type that accounts for just 2% of all thyroid cancers. The drug combination targets a certain genetic mutation.

Skin Cancer

Libtayo (cemiplimab), an immunotherapy drug, is the first FDA-approval specifically for advanced squamous cell carcinoma of the skin. Most people with this type of cancer can be cured with surgery or radiation, but in some cases the cancer becomes advanced and these treatments may no longer be options.

Poteligeo (mogamulizumab) is a new treatment option for adults with certain types of skin lymphoma, a cancer of the white blood cells that starts in the skin. 

Multiple Cancer Types

For just the second time, the FDA approved a drug to treat tumors with a specific genetic change regardless of cancer type. Vitrakvi (larotrectinib) is for adults and children with solid tumors that test positive for NTRK gene changes, which can help cancerous tumors grow.

In 2017, the FDA approved Keytruda (pembrolizumab) for some adults and children with advanced solid tumors that have certain gene changes.