Breast CancerFDA Approvals, News & Updates

Drug Watch: Recently FDA-Approved Breast Cancer Treatments

There are more treatment options available for breast cancer than ever before – and more are coming. Here’s an overview of the most recently approved medicines.
April 2021 Part 1 of 3 – Breast Cancer Special Issue Series

The good news for people with breast cancer is there are more treatment options available now than ever before. And more are coming. In fact, in the past year, 5 medicines received approval from the Food and Drug Administration (FDA) to treat specific types of breast cancer. Keytruda and Trodelvy were approved for use in triple-negative breast cancer, and Margenza, Nerlynx, and Tukysa were approved for use in HER2-positive breast cancer. Here we present an overview of each of these newly approved medicines.

Triple-Negative Breast Cancer

Keytruda (key-true-duh)

Generic name: pembrolizumab

What is it approved for? Keytruda may be used in combination with chemotherapy medicines when a breast cancer has returned and cannot be removed by surgery or has spread, and tests positive for PD-L1.

How does Keytruda work? Keytruda is an immunotherapy that works with your immune system to help fight certain cancers. The T-cells of the immune system circulate throughout your body to detect and fight infections and diseases, including cancer. Cancer cells may use the PD-1 pathway to hide from T-cells. Keytruda blocks the PD-1 pathway to prevent cancer cells from hiding, which allows the immune system to detect and destroy cancer cells.

What is PD-1 and PD-L1? PD-1 and PD-L1 are types of proteins found on cells in your body. The PD-1 protein is found on T-cells. PD-1 attaches to PD-L1, a protein found on some normal (and cancer) cells. This interaction tells the T-cells not to attack the other cells. Some cancer cells have large amounts of PD-L1, which helps them hide from a T-cell attack.

How is Keytruda given? Intravenous (IV) injection

Need help accessing Keytruda? Merck, the maker of Keytruda, offers the Merck Access Program. If you need information or help paying for Keytruda, you can contact the Merck Access Program at 1-855-257-3932 (or 1-855-257-7332 for the hearing impaired).

Patient Support Program: Patients can sign up for the KEY+YOU patient support program at or call 1-855-398-7832.


Trodelvy (tro-dell-vee)

Generic name: sacituzumab govitecan-hziy

What is it approved for? Trodelvy is approved for patients with triple-negative breast cancer that has spread outside of the breast to other parts of the body (also called metastatic). To receive treatment with this drug, patients must have received at least 2 prior therapies for metastatic disease.

How does Trodelvy work? Trodelvy consists of 3 parts: an antibody, an anticancer drug, and a linker that connects the anticancer drug to the antibody. Triple-negative breast cancer cells tend to contain a higher than normal level of a protein called Trop-2. The antibody in Trodelvy finds and sticks to the Trop-2 protein on the cancer cell. Once attached, Trodelvy delivers the anticancer drug directly into the cancer cell, which kills the cancer cell from within.

How is Trodelvy given? Intravenous (IV) injection

Need help accessing Trodelvy? Immunomedics, the maker of Trodelvy, offers Trodelvy Access Services, which is a patient access and reimbursement support program. This program will help you understand specific coverage and reimbursement guidelines. For more information, you can visit or call 1-844-TRODELVY (1-844-876-3358).


HER2-Positive Breast Cancer

Margenza (mar-gen-zuh)

Generic name: margetuximab-cmkb

What is it approved for? Margenza is approved for use in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2 regimens, at least 1 of which was for metastatic disease.

How is Margenza given? Intravenous (IV) infusion

Need help accessing Margenza? MacroGenics, the maker of Margenza, offers the Margenza Patient Support Program. Your healthcare provider can call 1-844-MED-MGNX to speak with a Case Manager who can assist with ordering information, reimbursement support, Patient Assistance Program, and Copay Assistance Program.

Be in the know: On the Margenza site, you can register for the latest information and updates about Margenza.


Nerlynx (ner-links)

Generic name: neratinib

What is it approved for? Nerlynx has 2 uses in HER2-positive breast cancers. It is approved for patients with early-stage HER2-positive breast cancer who have previously been treated with trastuzumab-based therapy. More recently, Nerlynx was approved to be used in combination with capecitabine (a chemotherapy) for advanced or metastatic HER2-positive breast cancer in patients who have received 2 or more anti-HER2 therapies.

What is the benefit of adding Nerlynx to capecitabine? For patients with metastatic breast cancer, Nerlynx may reduce the risk of cancer progression when used with capecitabine.

How is Nerlynx given? Oral tablet

Need help accessing Nerlynx? Puma Biotechnology, the maker of Nerlynx, offers the Nerlynx Quick Start program, a Patient Assistance Program, and Copay Support.

Patient support programs: Puma Biotechnology offers a Text Support Program that provides guidance and reassurance through e-mails and texts, a Mentor Program that will connect you with women who have taken Nerlynx, and a Nurse Support Program that gives you access to registered nurses who can answer any questions about Nerlynx.


Tukysa (too-KYE-sah)

Generic name: tucatinib

What is it approved for? Tukysa is approved to be given with the medicines Herceptin and Xeloda to treat HER2-positive breast cancer that has spread to other parts of the body or that cannot be removed by surgery, and who have received 1 or more anti-HER2 breast cancer treatments.

What is the benefit of adding Tukysa to Herceptin and Xeloda? Tukysa offers another chance at treating HER2-positive metastatic breast cancer. It may offer more time without the cancer growing and spreading and may help people live longer.

How is Tukysa given? Oral tablet

Need help accessing Tukysa? Seattle Genetics, the maker of Tukysa, can help if you need assistance paying for your medicine through their SeaGen Secure patient assistance program. Visit or call 1-855-4-SECURE for program information.

Ambassador Program: Seattle Genetics offers the Tukysa Ambassador Program where people share their experience with Tukysa to help educate, encourage, and inspire others. To learn more about the ambassador program, call 1-888-203-7601.


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Last modified: June 24, 2021

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