Update: FDA in the News: FDA approvals and health information on breast cancer

RELEVANCE

Most relevant for: People with breast cancer or at high-risk of breast cancer.

It may also be relevant for:

• people with breast cancer
• people with triple negative breast cancer
• people with Her2-positive cancer
• people with metastatic or advanced cancer
• people with ER/PR + cancer
• people newly diagnosed with cancer

Relevance: Medium-High

Research Timeline: Post Approval

More rating details

The FDA has approved several new treatments for breast cancer and expanded a past approval. These new treatment updates include:

• Kisqali: Two combinations approved for treating high-risk, early-stage HR-positive breast cancer.
• Datroway: Approved for certain metastatic breast cancers.
• Itovebi: Approved as a combined therapy for breast cancers with PIK3CA tumor mutations that grow after hormone therapy treatment. Read our recent XRAY review for more information.
• Enhertu: Previously approved for HER2-positive metastatic breast cancer and now expanded to include HER2-low and HER2-ultralow cancers (formerly called HER2-negative). Read our recent XRAY review for more information.

These treatments reflect the progress being made to provide more targeted and effective breast cancer treatments. Below and on the next tab are additional details about Kisqali and Datroway.

Kisqali (ribociclib) combined treatment for early-stage, high-risk breast cancer

Kisqali is a type of targeted therapy known as a CDK4/6 inhibitor. Kisqali was recently approved for treating hormone receptor-positive (HR-positive) breast cancer. Combining Kisqali with a type of hormone therapy known as an aromatase inhibitor may provide greater benefit than treatment with an aromatase inhibitor alone.

Kisqali can be taken in one of two ways:

• As two separate pills: Kisqali with any aromatase inhibitor.
• As a single pill: Kisqali Femara Co-Pack. This combines Kisqali and Femara (letrozole), which is a type of aromatase inhibitor. These combined treatments are usually taken once daily for 21 days, followed by 7days off in a 28-day cycle.

These therapies are approved for people with stage 2 or stage 3 breast cancer that is HR-positive, HER2-negative and considered at high risk for recurrence.

Kisqali side effects

Most side effects experienced by study participants were mild to moderate. The most common side  effects were:

• Low blood cell counts (low neutrophils and white blood cells)
• Infections
• Fatigue
• Nausea
• Headache
• Liver problems

More serious side effects (grades 3-4) were rare but included:

• Low white blood cell counts
  • 1% required discontinuing treatment
• Serious infections and skin conditions
• Changes in heart rhythms (QT interval changes)
  • Most heart rhythm changes were reversible. However, one person who had both low potassium levels and a heart rhythm change died suddenly.
• Liver problems
• Lung inflammation (ILD)
  • This is a rare but potentially life-threatening side effect that affects lung function. Symptoms include shortness of breath, cough and fatigue. This side effect is serious but treatable when caught early.

To monitor safety, regular heart and blood tests are done before and during treatment with Kisqali.

In the MONALESSA-7 study, 7% of people taking tamoxifen had a similar heart problem (prolonged QT interval). This was more frequent among people on Kisqali and tamoxifen (16%). Because the risk of this problem was higher when both drugs were taken together, the FDA recommends avoiding using tamoxifen and Kisqali at the same time.

Additionally, Kisqali could harm fetuses during pregnancy, so avoiding pregnancy is recommended during treatment and for at least three weeks after the final dose.

Datroway (datopotamab deruxecan-dlnk) for advanced breast cancer

Datroway is a new treatment option for people with metastatic breast cancer that:

• is hormone receptor-positive (HR-positive)
• is HER2-negative
• has already been treated with both hormone therapy and chemotherapy

Datroway is a type of targeted therapy known as an antibody-drug conjugate (ADC). The antibody portion delivers cancer-killing medicine directly to cancer cells that have a protein known as TROP2.

FDA approval was based on results from a clinical trial called TROPION-Breast01, which included 732 people with advanced breast cancer who had previously had one or two lines of chemotherapy and were no longer responding to hormone therapy. Participants were randomly chosen to receive either Datroway or standard chemotherapy chosen by their physician.

Key findings

Participants who took Datroway:

• had a longer time before the cancer worsened
  • Participants who received Datroway had 6.9 months before their cancer grew compared to 4.9 months among those treated with chemotherapy.
• more often had tumors shrink
  • 36% of participants on Datroway had their tumor shrink compared to 23% of participants on chemotherapy.
• had similar overall survival
  • Participants taking Datroway and those taking chemotherapy survived for just under 19 months after treatment began.

Datroway side effects

Most side effects of Datroway were mild to moderate; however, severe side effects occurred in some participants.

The most common side effects included mouth sores, nausea, eye problems and blood or metabolic abnormalities. Many of these side effects responded to treatment.

* Interstitial lung disease (ILD) was rare (under 1%) but serious.

Most people who experienced lung inflammation recovered, but one person died from this complication. Doctors closely monitored for initial symptoms of ILD, which can include cough, shortness of breath, fever or other new or worsening respiratory symptoms.

Office of Women’s Health

This year marks the 30th anniversary of the FDA’s Office of Women’s Health (OWH). Since its creation in 1994, OWH has improved women’s health through research, education and public outreach.

OWH has supported over 400 research projects on important women’s health issues, such as heart disease, breast cancer and pregnancy-related conditions. This research helps to ensure that differences between women and men are considered in medical research and drug approvals.

Take Time to Care Program

In 1998, OWH launched the Take Time to Care (TTTC) program. This important initiative helps women access reliable, easy-to-understand health information, such as fact sheets, videos, webinars and free educational materials that support informed health decisions. The TTTC covers key women’s health topics such as birth control, menopause, medication safety and breast health (including the Pink Ribbon Guide).

To help share these resources with the community, OWH partners with healthcare providers, community groups, faith-based organizations, universities and more. Materials are available for free download or by mail in English, Spanish and many other languages.

Explore more about the health topics covered by the OWH and view or download their free publications.

Finding safe, high-quality mammography services

The Mammography Quality Standards Act (MQSA) is a federal law enacted in 1992 to ensure that mammography services in the U.S. are safe, reliable and of high quality. Its primary goal is to aid in the early detection of breast cancer by setting national standards for mammography facilities.

Find a MQSA-approved mammography service center near you.

Birth control information

The FDA offers helpful information about various birth control (contraceptive) methods to support informed choices about preventing pregnancy.

Many options are available; however, some methods are more effective than others. The best choice for you depends on your health, lifestyle and personal preferences.

The FDA also provides printable information from research studies of real-life use that shows the effectiveness of each method. The information is based on how many of 100 participants might become pregnant in one year while using a specific method. These rates help show how well different methods work in real-life situations.

If you are thinking about birth control, a healthcare provider can further explain your options to find the method that’s right for you.

Reference

U.S. Food and Drug Administration. FDA approves ribociclib with an aromatase inhibitor and ribociclib and letrozole co-pack for early high-risk breast cancer. FDA. Published September 17, 2024. Accessed May 24, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ribociclib-aromatase-inhibitor-and-ribociclib-and-letrozole-co-pack-early-high-risk

U.S. Food and Drug Administration. FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer. FDA. Published January 17, 2025. Accessed May 24, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast

U.S. Food and Drug Administration. FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer. FDA. Published January 27, 2025. Accessed May 27, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2

U.S. Food and Drug Administration. Birth Control. FDA. Published 2024. Accessed May 27, 2025. https://www.fda.gov/consumers/womens-health-topics/birth-control

U.S. Food and Drug Administration. Free Publications for Women. FDA. Published January 30, 2025. Accessed May 27, 2025. https://www.fda.gov/consumers/womens-health-topics/free-publications-women

U.S. Food and Drug Administration. Mammography information for patients. FDA. Published 2024. Accessed May 27, 2025. https://www.fda.gov/radiation-emitting-products/mammography-quality-standards-act-mqsa-and-mqsa-program/mammography-information-patients

U.S. Food and Drug Administration. Take Time to Care Program. FDA. Published 2024. Accessed May 27, 2025. https://www.fda.gov/consumers/owh-historical-information/take-time-care-program

U.S. Food and Drug Administration. Women's Health Topics. FDA. Published January 31, 2025. Accessed May 27, 2025. https://www.fda.gov/consumers/womens-health/womens-health-topics

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to ensure scientific integrity.

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posted 8/4/25