Update: Approval of New Breast Cancer Drugs Increases Treatment Options

Datroway (datopotamab deruxtecan-dlnk)

What is this update about?
On May 22, 2026, the Food and Drug Administration approved Datroway (datopotamab deruxtecan-dlnk or Dato-DXd) for people with unresectable or metastatic triple-negative breast cancer (TNBC) for whom treatment with immunotherapy (PD-1/PD-L1 inhibitors) is not an option. A biomarker test called PD-L1 expression can help people with TNBC learn if PD-1/PD-L1 inhibitors are an option for them.

What is Datroway?

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 too much of a protein known as TROP2. Too muchTROP2 protein is common in breast cancer.

Datroway was previously approved as a treatment option for people with metastatic breast cancer that:

• is hormone receptor-positive (HR-positive).
• is HER2-negative.
• recurred or worsened after treatment with both hormone therapy and chemotherapy.

A similar drug, Trodelvy (sacituzumab govitecan) is approved for:

• metastatic TNBC that progressed, recurred or did not respond to at least two previous lines of treatment, and at least one of them was for metastatic disease.
• Unresectable, locally advanced or metastatic HR- positive, HER2-negative breast cancer that progressed, recurred or did not respond to previous hormone therapy and other systemic treatments for metastatic breast cancer.

Why is this approval important?

Metastatic TNBC is an aggressive cancer with few treatment options, and choices can be especially limited for people who are not eligible for PD-1/PD-L1 inhibitors.

Datroway can now also be used for some people with metastatic TNBC when PD-1/PD-L1 inhibitors are not an option, either as a first treatment or after other treatments. This gives people with metastatic TNBC another treatment choice at different points in care.

You can read more about Datroway’s previous approval here.

Study findings

The effectiveness of Datroway was evaluated in the TROPION-Breast02 (NCT05374512) trial. Researchers compared Datroway with standard chemotherapy in 644 participants with unresectable or metastatic TNBC who:

• had not received prior chemotherapy or other therapies for unresectable or metastatic breast cancer, and
• were not candidates for PD-1/PD-L1 inhibitor therapy.

Patients were randomly assigned to receive either Datroway (323 people) or chemotherapy (321 people).

People who received Datroway lived longer without their cancer growing or spreading. Time until cancer came back was:

• almost 11 months for participants who received Datroway compared to just under 6 months for those who received chemotherapy.

People who received Datroway also lived longer overall. Overall survival was:

• almost 24 months for those who received Datroway compared to 19 months for those who received chemotherapy.

Datroway side effects

The most common side effects included:

• mouth sores
• nausea
• eye problems
• fatigue
• hair loss
• constipation
• blood or metabolic abnormalities

Rare serious side effects included:

• interstitial lung disease (ILD)

Less than 1% of people in TROPION-Breast02 developed ILD. Doctors should closely monitor people taking Datroway for initial symptoms of ILD. These include cough, shortness of breath, fever or other new or worsening respiratory symptoms.

What does this mean for me?
If you have unresectable or metastatic TNBC and are not a candidate for PD-1/PD-L1 therapy, you may want to ask your doctor if Datroway is a treatment option for you.

Questions to ask your Dr

• Have I had tumor testing?
• Am I a candidate for PD-1/PDL-1 therapy?
• Is Datroway an option for me?
• What options do I have before trying Datroway?

Reference
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer. News Release. FDA. May 22, 2026.

What is this update about?
 

On May 1, 2026, the FDA approved Veppanu (vepdegestrant) for people with advanced or metastatic breast cancer that:

• is ER-positive.
• is HER2-negative.
• has a biomarker known as an ESR1 mutation.
• has progressed after at least one hormone therapy treatment.

The FDA also approved a test called Guardant360 CDx to help identify patients who have an ESR1 mutation and may benefit from Veppanu.

What is Veppanu?

Veppanu is a type of hormone therapy known as a selective estrogen receptor degrader (SERD). It is taken as a pill.

Like other SERDs, such as Faslodex (fulvestrant), Inluriy (imlunestrant) and Oserdu (elacestrant), Veppanu binds the estrogen receptor but works differently: it adds small molecules to the estrogen receptor which signal cells to destroy it.

Study findings

Veppanu approval was based on the phase 3 VERITAC-2 trial. Participants received either Veppanu by daily oral pill or Fulvestrant, another type of SERD, as an intramuscular injection. Results of this trial showed that patients with ESR1-mutated tumors had a longer time until their cancer came back (progression-free survival) with Veppanu than with fulvestrant

In people whose tumors had an ESR1 mutation, time until cancer came back was:

• 5 months among patients who received Veppanu compared to 2 months among patients who received Fulvestrant.
• Overall survival data were not yet available when the drug was approved.

Patients who benefited the most were those whose tumors had an ESR1 mutation. This supports the need for biomarker testing because it can help identify who may benefit most from Veppanu. That is why the FDA also approved the Guardant360 CDx test along with approval of Veppanu.

Veppanu side effects

The most common side effects include:

• Fatigue
• Nausea
• Elevated liver enzymes
  • Elevated liver enzymes indicate that the liver may need to be monitored during treatment.
• Joint and back pain.
• Low red blood cell counts (anemia) and low white blood cell counts (neutropenia)

Rare serious side effects include:

• Changes in heart rhythm.
  • People taking Veppanu may need periodic EKG monitoring.
• Harm to an unborn baby.
  •  Veppanu must not be taken during pregnancy.

Talk with your healthcare team about the risks and benefits of treatment.

What does this mean for me?

If you have ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, you may want to ask your doctor if Veppanu is a treatment option for you.

Questions to ask your Dr

• Have I had tumor testing?
• Does my cancer have an ESR1 mutation?
• Am I a candidate for treatment with Veppanu?
• What are the possible side effects?
• What are my other treatment options?

Reference
FDA approves vepdegestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. News Release. FDA. May 1, 2026.

 

 

What is this update about?

On May 15, 2026, the FDA approved two uses of Enhertu (fam-trastuzumab deruxtecan-nxki or T-DXd) for HER2-positive early-stage breast cancer:

• Before surgery (neoadjuvant) in people with stage 2 or stage 3 HER2-positive breast cancer
• After surgery (adjuvant) in people with HER2-positive breast cancer that remains after neoadjuvant treatment

Companion HER2 diagnostic tests were also approved.

Why is this update important?

Previously, Enhertu was only approved for people with metastatic breast cancer. These two new approvals allow Enhertu to be used earlier in treatment for some people with HER2-positive, early-stage breast cancer. This provides patients and doctors with another option before surgery and after surgery.

You can read more about Enhertu here and here.

What is Enhertu?

Enhertu is a type of targeted therapy known as an antibody-drug conjugate. It combines an antibody that targets the protein HER2 with a chemotherapy drug and is designed to deliver treatment directly to cancer cells with HER2.

Study findings

Before surgery (neoadjuvant)

The effectiveness of neoadjuvant Enhertu was based on results from DESTINY-Breast11, a trial of 927 adults with HER2-positive, high-risk, early-stage breast cancer.

The absence of cancer in lymph nodes after surgery was:

• 67% of the group that received Enhertu.
• 56% of the other two study groups that received other treatments.

After surgery (adjuvant)

The effectiveness of Enhertu for adjuvant treatment was evaluated in the DESTINY-Breast05 trial. This trial enrolled 1,635 adults with HER2-positive breast cancer that remained after neoadjuvant therapy. Patients received either Enhertu or another targeted therapy. 

Three years after treatment: 

• 92% of participants in the group that received Enhertu did not have their cancer return.
• 84% of participants in the group that received another targeted therapy did not have their cancer return.

Enhertu side effects

Common side effects included:

• loss of appetite
• nausea
• vomiting
• hair loss
• diarrhea
• constipation
• upper respiratory tract infections
• increases and/or decreases in minerals, such as potassium
• decreases in both red and white blood cell counts

Enhertu Boxed Warning

The Enhertu Boxed Warning alerts healthcare providers and patients to the risk of a group of lung diseases collectively known as interstitial lung disease (ILD). ILD causes scarring of the lungs, which creates stiffness that makes it difficult to breathe and get oxygen into the blood.

Severe, life threatening and fatal cases of ILD have been reported with Enhertu.

It is important to talk with your healthcare team about symptoms to watch for and whether you may be at higher risk of experiencing ILD.

What does this mean for me?

If you have stage 2 or stage 3 HER2-positive breast cancer, ask your doctor if Enhertu is a treatment option for you.

Questions to ask your Dr

• Have I had biomarker testing?
• Is my tumor HER2-positve?
• Is Enhertu an option for me?
• What are my other options??
• Am I a candidate for Enhertu if I have a history of lung issues?

Reference

FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer. News Release. FDA. May 15, 2026.

These approvals show how breast cancer treatment is becoming more personalized. Biomarker testing is increasingly being used to match patients with treatments that may work best for their specific cancer.

Now, newer treatments are being matched to biomarkers, such as HER2 expression or ESR1 mutation status. Additionally, researchers are studying treatments at earlier stages of cancer, including before surgery (neoadjuvant) and after surgery (adjuvant).

As new treatments become available, biomarker testing will continue to hold an important role in helping patients and their healthcare teams make treatment decisions.

Not every treatment is right for every person. Options depend on the type and stage of breast cancer, previous treatments and the results of tumor testing. Talk with your healthcare team about options that may be appropriate for you.

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 assure scientific integrity.

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posted 6/22/2026