Skip to main content

ACS & ASCO are Stronger Together: Cancer.Net content is now available on


2019 in Review: New Cancer Drug Approvals

close up of a microscope

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 treatments include targeted therapy, which aims to more precisely identify and go after 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.

Before any new drug can be sold in the United States, it goes 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 2019, the FDA approved several new drug treatments for different cancer types that American Cancer Society editors believe will make a significant difference.

Bladder Cancer

Balversa (erdafitinib) is the first targeted therapy approved for bladder cancer. The FDA approved this drug in April for adults with advanced bladder cancer with a mutation in the FGFR3 or FGFR2 gene, and that has gotten worse after treatment with chemotherapy. The FDA also approved a test to look for these gene mutations.

Breast Cancer

In March, the FDA approved the first immunotherapy treatment for breast cancer. It’s a combination of Tecentriq (atezolizumab) and Abraxane (nab-paclitaxel) for people with advanced triple negative breast cancer. There are few other treatments available for this aggressive cancer type.

In May, the FDA approved the targeted therapy Piqray (alpelisib) for a type of breast cancer caused by a certain inherited genetic mutation. It’s the first treatment of its kind for this cancer type.

Head and Neck Cancer

The immunotherapy drug Keytruda (pembrolizumab) was approved in June as a first-line, or initial, treatment for people with advanced head and neck cancer. Keytruda is also used to treat people with several other cancer types.

Lung Cancer

The FDA approved Tecentriq (atezolizumab) in March as the second immunotherapy drug for people with advanced small cell lung cancer, and the first for use as part of first-line treatment. Tecentriq is also used to treat people with several other cancer types.


In June, the FDA approved the first antibody-drug conjugate to treat diffuse large B-cell lymphoma, the most common type of non-Hodgkin lymphoma in the US. An antibody-drug conjugate is a targeted drug combined with chemotherapy. The targeted drug finds the cancer cell and then delivers the chemo to destroy it. The new drug, Polivy (polatuzumab vedotin-piiq), is approved to be used along with the chemotherapy drug bendamustine and a rituximab product.

Multiple Cancer Types

For just the third time, the FDA approved a drug to treat tumors with a specific genetic change regardless of cancer type. Rozlytrek (entrectinib) was approved in August for adults and adolescents with tumors that test positive for NTRK gene changes, which can help cancerous tumors grow.

The American Cancer Society medical and editorial content team

Our team is made up of doctors and oncology certified nurses with deep knowledge of cancer care as well as editors and translators with extensive experience in medical writing.