Two important FDA approvals in 2026 have expanded treatment options for triple-negative breast cancer (TNBC). Datroway (datopotamab deruxtecan-dlnk) and Trodelvy (sacituzumab govitecan-hziy) are targeted treatments known as antibody-drug conjugates (ADCs).
These medications deliver powerful chemotherapy drugs to cancer cells using antibodies that recognize specific proteins on the cells. Clinical trials have shown that these treatments can delay cancer progression compared with standard chemotherapy in certain patients with advanced triple-negative breast cancer.
The new approvals are especially important for patients with unresectable locally advanced or metastatic TNBC, meaning cancer that cannot be removed through surgery or has spread beyond the breast.
THE BASICS: In May 2026, the FDA approved Datroway for certain patients with advanced TNBC who are not candidates for PD-1/PD-L1 immunotherapy. In June 2026, the FDA expanded Trodelvy's approval to include first-line treatment, either alone or with pembrolizumab (Keytruda), depending on immunotherapy eligibility and PD-L1 status. These approvals provide additional options for patients with advanced TNBC.
What is triple-negative breast cancer?
Triple-negative breast cancer is a type of breast cancer that tests negative for three important markers:
Estrogen receptors (ER): Proteins that allow estrogen to stimulate cancer growth.
Progesterone receptors (PR): Proteins that can help cancer cells respond to progesterone.
HER2: A protein that can promote cancer cell growth when present at unusually high levels.
When a breast biopsy confirms cancer, the tissue is tested for these markers. If the tumor is ER-negative, PR-negative, and HER2-negative, it is classified as triple-negative breast cancer.
TNBC accounts for approximately 10%–15% of breast cancer diagnoses. It tends to grow more quickly than many other breast cancer types and has a higher risk of recurrence, particularly during the first several years after diagnosis.
Triple-negative breast cancer is more common among younger women and people with inherited BRCA1 mutations. However, it can affect people of any age, and many patients do not have an inherited cancer-related mutation.
Because TNBC lacks the hormone receptors and HER2 overexpression targeted by many other breast cancer treatments, doctors often rely on chemotherapy, surgery, radiation therapy, immunotherapy, and other targeted treatments.
What are antibody-drug conjugates (ADCs)?
Antibody-drug conjugates are cancer treatments that combine an antibody with a chemotherapy drug.
An ADC has three main components:
Antibody: Recognizes and attaches to a specific protein on or near cancer cells.
Chemotherapy drug: Damages cancer cells after being delivered by the antibody.
Linker: Connects the antibody and chemotherapy drug until the medication is released.
Both Datroway and Trodelvy target a protein called Trop-2, which is found on many triple-negative breast cancer cells.
By targeting Trop-2, these medications help deliver chemotherapy to tumors. However, some chemotherapy can also affect healthy tissues, meaning ADCs can still cause significant side effects.
Datroway: FDA-approved treatment for advanced TNBC
Datroway (datopotamab deruxtecan-dlnk) received FDA approval for triple-negative breast cancer on May 22, 2026.
The approval covers adults with unresectable or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor immunotherapy.
Datroway was previously approved for other cancer indications, but the 2026 approval expanded its use to this group of patients with TNBC.
How does Datroway work?
Datroway is an antibody-drug conjugate that targets Trop-2.
The antibody attaches to Trop-2 on cancer cells and delivers a chemotherapy payload called deruxtecan (DXd). This drug interferes with an enzyme that cancer cells need to copy and repair their DNA.
By damaging cancer cell DNA, Datroway can prevent cells from multiplying and cause them to die.
Datroway is administered through an intravenous infusion, generally once every three weeks.
TROPION-Breast02 clinical trial results
The phase III TROPION-Breast02 trial (NCT05374512) enrolled 644 adults with unresectable or metastatic triple-negative breast cancer who were not candidates for PD-1/PD-L1 immunotherapy.
Patients had not previously received systemic treatment for unresectable or metastatic disease. Researchers compared Datroway with standard chemotherapy selected by the treating physician.
The results showed:
Outcome | Datroway | Standard chemotherapy |
|---|---|---|
Median progression-free survival | 10.8 months | 5.6 months |
Median overall survival | 23.7 months | 18.7 months |
Tumor response rate | 64% | 30% |
Progression-free survival measures how long patients live without their cancer growing or spreading. Overall survival measures how long patients live after beginning treatment, regardless of whether the cancer progresses.
Datroway reduced the relative risk of disease progression or death by approximately 43% compared with chemotherapy during the trial's follow-up period.
These results demonstrate that Datroway can improve cancer control and overall survival in the patient population studied. They do not mean every patient will experience the same benefit.
What are the side effects of Datroway?
Common side effects may include:
Mouth sores or inflammation of the mouth (stomatitis)
Nausea and vomiting
Fatigue
Hair loss or thinning
Constipation
Dry eyes or other eye problems
Serious risks include:
Interstitial lung disease (ILD) or pneumonitis: Inflammation of the lungs that can become life-threatening. Report a new or worsening cough, shortness of breath, or fever immediately.
Eye complications: Datroway can cause changes affecting the surface of the eye, including potentially serious corneal problems. Eye examinations and monitoring may be recommended.
Severe mouth sores: Painful inflammation can interfere with eating, drinking, and swallowing. Your care team may recommend preventive mouth care, including a steroid-containing mouthwash.
Tell your oncology team about side effects early. Treatment adjustments and supportive medications may help manage symptoms.
Trodelvy: Expanded FDA approval for TNBC in 2026
Trodelvy (sacituzumab govitecan-hziy) is another Trop-2-directed antibody-drug conjugate.
Trodelvy was already FDA-approved for certain patients with previously treated metastatic TNBC. On June 24, 2026, the FDA expanded its approval to include two first-line treatment approaches.
These approvals mean that eligible patients may now receive Trodelvy earlier in their treatment.
How does Trodelvy work?
Trodelvy combines an antibody that targets Trop-2 with SN-38, the active metabolite of the chemotherapy drug irinotecan.
After the antibody binds to Trop-2, SN-38 is released and damages cancer cell DNA, helping prevent the cells from growing and dividing.
Trodelvy is administered through an intravenous infusion on days 1 and 8 of a 21-day treatment cycle.
Who can receive Trodelvy for triple-negative breast cancer?
Trodelvy has several FDA-approved uses for unresectable locally advanced or metastatic TNBC:
First-line treatment without immunotherapy: Trodelvy can be used alone for adults who are not candidates for PD-1/PD-L1 inhibitor-based therapy.
First-line treatment with immunotherapy: Trodelvy can be combined with pembrolizumab (Keytruda) for adults whose tumors express PD-L1 with a combined positive score (CPS) of at least 10, determined by an FDA-authorized test.
Later-line treatment: Trodelvy can be used after two or more previous systemic therapies, including at least one treatment for metastatic disease.
A patient's PD-L1 test results, previous treatments, and overall health help determine which approach may be appropriate.
ASCENT-03 trial: Trodelvy compared with chemotherapy
The phase III ASCENT-03 trial (NCT05382299) evaluated Trodelvy as a first-line treatment for patients with unresectable locally advanced or metastatic TNBC who were not candidates for PD-1/PD-L1 immunotherapy.
The study included 558 patients and compared Trodelvy with standard chemotherapy.
Results showed:
Outcome | Trodelvy | Standard chemotherapy |
|---|---|---|
Median progression-free survival | 9.7 months | 6.9 months |
Tumor response rate | 50% | 47% |
Trodelvy reduced the relative risk of disease progression or death by 38% compared with standard chemotherapy.
Although the improvement in tumor response rate was relatively small, patients receiving Trodelvy experienced a longer median period without cancer progression.
Overall survival data were not yet mature at the time of the FDA approval.
ASCENT-04 trial: Trodelvy plus Keytruda
The phase III ASCENT-04/KEYNOTE-D19 trial (NCT05382286) evaluated Trodelvy combined with pembrolizumab (Keytruda).
The study enrolled 443 patients with previously untreated, unresectable locally advanced or metastatic TNBC whose tumors expressed PD-L1 with a CPS of at least 10.
Researchers compared Trodelvy plus Keytruda with standard chemotherapy plus Keytruda.
Results showed:
Outcome | Trodelvy + Keytruda | Chemotherapy + Keytruda |
|---|---|---|
Median progression-free survival | 11.2 months | 7.8 months |
Tumor response rate | 61% | 55% |
The combination reduced the relative risk of disease progression or death by 35% compared with chemotherapy plus Keytruda.
These results supported the FDA's June 2026 approval of Trodelvy combined with pembrolizumab for eligible patients with PD-L1-positive advanced TNBC.
Overall survival results were still immature at the time of approval.
What are the side effects of Trodelvy?
Common side effects of Trodelvy include:
Low white blood cell counts
Anemia
Nausea and vomiting
Diarrhea or constipation
Fatigue
Hair loss
Decreased appetite
Changes in certain blood test results
Trodelvy also carries important warnings for potentially serious complications.
Severe neutropenia
Neutropenia occurs when the number of infection-fighting white blood cells becomes dangerously low.
Severe neutropenia increases the risk of serious infections. Patients receiving Trodelvy need regular blood tests, and some may receive medications to stimulate white blood cell production.
A fever during treatment can be a medical emergency and should be reported immediately.
Severe diarrhea
Trodelvy can cause severe diarrhea, potentially leading to dehydration and electrolyte imbalances.
Your oncology team may recommend medications to manage diarrhea and may temporarily pause or adjust treatment if symptoms become severe.
Infusion reactions and other risks
Some patients experience allergic or infusion-related reactions, including chills, difficulty breathing, dizziness, or swelling.
Trodelvy can also cause significant nausea and vomiting. Preventive medications are commonly given to reduce these symptoms.
Patients receiving Trodelvy with Keytruda must also be monitored for immunotherapy-related side effects, including inflammation affecting the lungs, intestines, liver, thyroid, or other organs.
Datroway vs. Trodelvy: What is the difference?
Although Datroway and Trodelvy both target Trop-2, they contain different chemotherapy payloads and have different FDA-approved uses.
Feature | Datroway | Trodelvy |
|---|---|---|
Generic name | Datopotamab deruxtecan | Sacituzumab govitecan |
Drug type | Antibody-drug conjugate | Antibody-drug conjugate |
Target | Trop-2 | Trop-2 |
Chemotherapy payload | Deruxtecan (DXd) | SN-38 |
2026 TNBC approval | May 22, 2026 | June 24, 2026 |
First-line use without immunotherapy | Yes, for eligible patients | Yes, for eligible patients |
First-line use with Keytruda | Not approved for this combination | Yes, for PD-L1 CPS ≥10 |
Important safety concerns | Lung inflammation, eye problems, mouth sores | Low white blood cell counts, severe diarrhea |
Which treatment is better?
There is no definitive answer for every patient. Datroway and Trodelvy were studied in separate clinical trials with different patient populations and treatment comparisons.
Their results cannot be used to conclude that one medication is more effective than the other without a direct comparative study.
Your oncologist will consider the cancer's characteristics, previous treatments, other medical conditions, side effects, and your treatment preferences.
Do these treatments cure triple-negative breast cancer?
Datroway and Trodelvy have demonstrated benefits in controlling advanced TNBC, but neither is considered a guaranteed cure for metastatic breast cancer.
For patients with early-stage triple-negative breast cancer, treatment may aim to cure the disease. Depending on the diagnosis, treatment can include chemotherapy, immunotherapy, surgery, radiation, and certain targeted medications.
The 2026 approvals discussed here apply to specific populations with unresectable locally advanced or metastatic TNBC, not all patients with newly diagnosed triple-negative breast cancer.
Frequently asked questions about new TNBC treatments
Are Datroway and Trodelvy chemotherapy?
Both are antibody-drug conjugates that contain chemotherapy medications. They are considered targeted drug-delivery treatments, but they are not chemotherapy-free.
Do patients need Trop-2 testing before treatment?
Both drugs target Trop-2, but their FDA-approved TNBC indications do not require patients to have a Trop-2-positive test result.
Other biomarker testing, particularly PD-L1 testing, can be important when selecting treatment.
What does PD-L1-positive TNBC mean?
PD-L1 is a protein involved in regulating immune responses. Certain breast cancers express PD-L1, which can help determine eligibility for immunotherapy-based treatments.
For first-line Trodelvy plus pembrolizumab, the FDA requires a PD-L1 combined positive score of at least 10 using an authorized test.
Are these treatments available for early-stage TNBC?
The 2026 TNBC approvals for Datroway and Trodelvy focus on unresectable locally advanced or metastatic disease.
Patients with early-stage TNBC may have different treatment options, and clinical trials are investigating additional uses of ADCs.
Questions to ask your oncologist about TNBC treatments
If you have triple-negative breast cancer, consider asking:
Is my cancer eligible for treatment with Datroway or Trodelvy?
Has my tumor been tested for PD-L1?
Would immunotherapy be appropriate for me?
How do these treatments compare with my current options?
What side effects should I expect?
How will we know whether treatment is working?
Would biomarker or genetic testing help guide my treatment?
Are there clinical trials investigating new TNBC treatments that I should consider?
What do the 2026 FDA approvals mean for TNBC patients?
The 2026 FDA approvals of Datroway and Trodelvy represent important advances in treating triple-negative breast cancer.
Both medications use Trop-2-directed antibody-drug conjugate technology to deliver chemotherapy to cancer cells. Clinical trials have demonstrated meaningful improvements in progression-free survival compared with standard chemotherapy in specific groups of patients.
Datroway also demonstrated an overall survival benefit in TROPION-Breast02, while Trodelvy's expanded approvals provide additional first-line options both with and without immunotherapy.
These treatments carry potentially serious side effects and are not appropriate for every patient. However, their availability gives oncologists more ways to personalize treatment for people with advanced TNBC.
As research continues, new clinical trials may help determine how antibody-drug conjugates can be combined with other therapies or used at different stages of breast cancer.
