Datopotamab deruxtecan-dlnk (Datroway) 2025 Guides: What Patients Need to Know?

Datopotamab deruxtecan-dlnk is a new type of targeted cancer therapy known as an antibody-drug conjugate (ADC). It was developed by Daiichi Sankyo and co-developed with AstraZeneca, and has received FDA approval in 2025 for the treatment of advanced breast cancer and lung cancer in specific patient groups. In this article, we’ll explore how Datroway works, the cancers it treats, what to expect during treatment, and the latest updates from clinical trials.

What Is Datopotamab Deruxtecan and How Does It Work?

Datopotamab deruxtecan-dlnk, sold under the brand name Datroway, is a targeted therapy that delivers chemotherapy directly to cancer cells. It combines two parts:

• An antibody that targets a protein called Trop-2, found on many cancer cells.
• A chemotherapy drug (DXd) attached to the antibody.

Once the drug finds and binds to Trop-2, it enters the cancer cell and releases the chemotherapy from within. This focused delivery can destroy the cancer cell while sparing more healthy cells than traditional chemotherapy.

What Cancers Does It Treat?

Datroway is FDA-approved for:

• Hormone receptor–positive, HER2-negative advanced breast cancer, including HER2-low tumors, in adults who’ve had prior hormone therapy and chemotherapy.
• EGFR-mutated non–small cell lung cancer (NSCLC) in adults who’ve already been treated with EGFR-targeted therapy and platinum-based chemotherapy.

In both cases, the drug is used after other treatments have stopped working and targets tumors that express the Trop-2 protein.

Clinical Trial Results and Effectiveness

Datopotamab deruxtecan-dlnk (Datroway) was approved by the FDA based on strong results from clinical trials in patients with advanced breast and lung cancers that had stopped responding to other treatments.

Datroway For Breast Cancer

The approval for hormone receptor-positive, HER2-negative breast cancer came from the TROPION-Breast01 trial, which included over 700 patients. This study compared Datroway to standard chemotherapy options. Patients who received Datroway stayed free from cancer progression longer—6.9 months compared to 4.9 months with chemotherapy. The drug also helped shrink tumors in 36% of patients, compared to 23% with standard treatment. These results were published in The Journal of Clinical Oncology in 2024.

Datroway For Lung Cancer

The approval for EGFR-mutated non-small cell lung cancer (NSCLC) came from two studies: TROPION-Lung01 and Lung05. These trials included patients who had already tried EGFR-targeted drugs and chemotherapy. Datroway was shown to shrink tumors in 45% of patients, with a median response lasting 6.5 months. The drug is given through an IV every 3 weeks. Together, these studies showed that Datroway can offer meaningful benefits when other treatments no longer work.

What Is a Clinical Trial and Why Does It Matter?

A clinical trial is a research study designed to test new drugs and treatments in patients to determine their safety and effectiveness. Before Datroway was approved, it went through multiple phases of clinical trials to assess how well it worked, what side effects it caused, and whether it was better than existing treatments. Clinical trials are essential because they provide scientific evidence that a drug can help patients while ensuring it is safe for widespread use.

What Does FDA Approval Mean?

When a drug receives FDA approval, it means that after rigorous testing in clinical trials, it has been shown to be both safe and effective for treating a specific condition. This approval makes the drug widely available for doctors to prescribe and helps patients access new, cutting-edge treatments sooner.

Side Effects and How to Manage Them?

Datopotamab deruxtecan-dlnk (Datroway) is a targeted therapy for advanced breast and lung cancers. It delivers chemotherapy directly into cancer cells by targeting a protein called Trop-2. Like all cancer treatments, it can cause side effects—some mild and others more serious.

Common Side Effects

Many patients experience manageable symptoms such as tiredness, nausea, vomiting, constipation, mouth sores, dry eyes, and hair thinning. Blood tests may show lower white or red blood cell counts, or slight changes in liver enzymes and calcium levels. These side effects usually happen in the early stages of treatment and can be controlled with supportive care. Ice chips may ease mouth sores, artificial tears can relieve dry eyes, and medications can reduce nausea. A high-fiber diet, fluids, and rest are also helpful.

Serious or Less Common Side Effects

Although rare, more serious side effects can occur. These include interstitial lung disease (lung inflammation), which may start as a dry cough or shortness of breath and could become dangerous if not treated early. Some people may have allergic reactions or infusion-related symptoms like fever, chills, or difficulty breathing. Vision problems and eye pain are possible in a small number of cases. Blood count issues may increase the risk of infection or bleeding.

Managing Side Effects During Treatment

Your doctor will monitor your blood work and symptoms regularly. Treatment may be paused or adjusted if serious issues arise. Most common side effects are manageable with medications, eye care, diet changes, or short breaks in treatment. If any new or unusual symptoms appear, it’s important to tell your healthcare team right away.

What to Expect Long-Term?

Datroway is not a cure, but it helps control cancer and delay progression in patients with few remaining options. Studies show lasting benefit, with some patients remaining on treatment for a year or longer. If the cancer worsens during treatment, your doctor will discuss next steps, including switching therapies.

Learn more about Breast Cancer: Symptoms Causes, Stages, Diagnosis and Treatment on OncoDaily.

Recommended Dosage of Datopotamab Deruxtecan-dlnk

Datopotamab deruxtecan-dlnk (Datroway) is given as an intravenous (IV) infusion every three weeks. The dose is based on your body weight—usually 6 mg per kilogram, with a maximum of 540 mg per treatment. Treatment continues until the cancer progresses or side effects become too difficult to manage. This medication is approved for advanced breast cancer (hormone receptor-positive, HER2-negative) in patients who have already received hormone therapy and chemotherapy. It’s also used for EGFR-mutated advanced non-small cell lung cancer (NSCLC) after prior targeted and chemotherapy treatments.

How the Drug Is Given?

The medicine is mixed carefully in a special sugar solution (not saltwater) and infused into a vein through a filter, while protected from light. The first treatment takes 90 minutes, with at least an hour of observation afterward. If there are no problems, future infusions take about 30 minutes.

Patients usually receive premedications—such as antihistamines, acetaminophen, or corticosteroids—before each infusion to prevent side effects. Ice chips may be used during the infusion to help reduce mouth sores. If a dose is missed or delayed, it should be given as soon as possible. The drug must be stored in a refrigerator and used within 24 hours after being prepared. It should never be frozen.

How Is Datroway Metabolized and Eliminated?

Datroway is processed inside cells by enzymes that release the chemotherapy drug (DXd). The antibody part is broken down like natural proteins. The DXd part is mainly metabolized by the liver enzyme CYP3A4.

• Clearance: About 0.6 liters/day (faster in people with higher body weight)
• Half-life: 4.8 days for Datroway, about 5.5 days for DXd

This means the drug stays in your body for several days, supporting its dosing every 3 weeks.

What to Avoid During Treatment?

During treatment with Datopotamab deruxtecan-dlnk (Datroway), it’s very important not to become pregnant or breastfeed, as the medication could harm a developing baby. Both men and women should use effective birth control during treatment and for some time afterward. Patients should also avoid live vaccines and try to stay away from people who are sick, as the immune system may be weakened during treatment. If you develop dry or irritated eyes, it’s best not to wear contact lenses and use artificial tears as recommended.

Learn more about Non-Small Cell Lung Cancer: Causes, Symptoms, Diagnosis, Treatment Options, and Latest 2025 Advances in Targeted and Immunotherapy on OncoDaily.

Ongoing Clinical Trials

Datopotamab deruxtecan (Dato-DXd) is still being studied in clinical trials to see how well it works in other cancer situations. One trial, called TUXEDO-5, is testing it in patients with non-small cell lung cancer (NSCLC) that has spread to the brain. Patients receive the drug every 3 weeks, and researchers are watching how well it controls brain tumors.

Another large study, TROPION-Lung14, is looking at whether combining Dato-DXd with osimertinib works better than osimertinib alone in people with advanced EGFR-mutated NSCLC who haven’t had previous treatment. This research will help show if the combination can improve outcomes for more patients.

Datopotamab deruxtecan-dlnk (Datroway) offers a promising new option for patients with advanced lung and breast cancers. With targeted action, manageable side effects, and strong trial results, it represents a major step forward—especially for those with limited treatment choices. Ongoing studies will reveal even more about its potential in the years to come.

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