Navigating NSCLC: What to Know About Datroway

Written by Patricia Weiser, PharmD
Medically Reviewed by Beth Johnston, PharmD, BCPS on August 12, 2025
9 min read

If you have non-small-cell lung cancer (NSCLC) with an EGFR mutation, your health care provider may recommend a new medicine called Datroway (datopotamab deruxtecan-dlnk).

NSCLC is the most common form of lung cancer. About one-third of cases involve a change, or mutation, in the epidermal growth factor receptor (EGFR) gene. EGFR proteins sit on the surface of many cells in your body and help control how cells grow and divide. When there is a mutation in the EGFR gene, these proteins can become overactive and make cancer cells grow and divide more quickly.

Most people with EGFR-mutated NSCLC start treatment with targeted medicines. These medicines usually work well at first, but over time they tend to stop working and the lung cancer starts growing again. Datroway offers a new option for people whose cancer has stopped responding to earlier treatments.

In June 2025, the FDA approved Datroway to treat EGFR-mutated NSCLC in people who have already tried certain treatments. Datroway belongs to a group of medicines called antibody-drug conjugates (ADCs). It is typically given as an infusion into a vein (IV) once every three weeks. 

Datroway is also commonly used to treat certain types of breast cancer. It may also be used for other conditions as determined by your health care provider. This article focuses on frequently asked questions about Datroway for NSCLC.

To see if Datroway is right for you, your health care provider will consider things like the type of lung cancer you have, whether it has spread, and the treatments you have already tried for it. They will also look at your overall health and test results from when you were first diagnosed to see if your cancer has EGFR mutations. Tests to check EGFR status do not usually need to be repeated before starting Datroway.

Datroway is FDA-approved to treat NSCLC in adults whose cancer meets all of the following requirements:

  • It’s EGFR-mutated, which means the cancer has certain abnormal proteins that tell the cancer cells to grow and multiply. Examples of EGFR mutations are exon 19 deletions, exon 21 L858R mutations, and T790M mutations, among others.  
  • The cancer has spread to nearby tissues (locally advanced) or has spread to distant parts of your body (metastatic).
  • It’s been treated with standard medicines. These include EGFR-targeted medicines (such as osimertinib), and platinum-based chemotherapy (such as cisplatin or carboplatin).

Datroway is only approved for use in adults. It is not known if this medicine is safe or effective for children.

Datroway is a type of targeted cancer treatment called an antibody-drug conjugate (ADC). It works like a targeted missile that seeks out certain cancer cells and delivers treatment directly inside them. It carries a powerful cancer-killing medicine linked to an antibody. 

The antibody part of Datroway searches for and attaches to a protein called Trop-2, which is found on many cells, including lung cancer cells. After attaching, Datroway enters the cancer cell. Inside, a special link breaks and releases a chemotherapy drug, called DXd, directly into the cell. DXd can then move through cell membranes and damage the cell’s DNA, which leads to cancer cell death. This helps slow cancer growth and may cause tumors to shrink.

Like other ADCs, Datroway is designed to deliver chemotherapy directly to cancer cells, which may limit harm to healthy cells. Even though Datroway is designed to target cancer cells, it can still cause side effects. While the side effects of targeted therapies tend to be less common and less severe than the side effects of chemotherapy, serious side effects are possible.

Datroway is given by a health care professional in a hospital or clinic. It is given as an infusion into a vein (intravenously). Datroway is usually given once every three weeks. The exact dosage depends on your body weight. 

The first infusion usually takes about 90 minutes. After that, each infusion usually takes about 30 minutes. You will be closely monitored during and after each infusion for side effects. Your care team will monitor you for at least one hour after the first two infusions. If you do not have any infusion-related reactions, the monitoring time may be reduced to about 30 minutes for future treatments.

Before each infusion, you may receive medicines to help lower your risk of side effects. These may include eye drops, a steroid mouthwash, acetaminophen, an antihistamine such as diphenhydramine, and medicines to prevent nausea. You may be asked to hold ice chips or cold water in your mouth during the infusion to help protect the inside of your mouth.

You will likely continue Datroway treatment for as long as the medicine is safe and effective for you. If you have certain side effects, your health care provider might pause your treatment or lower your dose. If you still have side effects after your dose is lowered, or if you have severe side effects or your cancer gets worse, your health care provider may stop your Datroway treatment.  

The effectiveness of Datroway for non-small-cell lung cancer was studied in two clinical trials called TROPION-Lung05 and TROPION-Lung01. These larger studies included people with advanced NSCLC who had received previous treatments. Researchers looked specifically at a subgroup of 114 adults whose cancer had an EGFR mutation. This pooled group was used to evaluate how well Datroway worked in people with this specific type of NSCLC.

The following information describes the 114 people in this subgroup:

  • The median age was 63, with ages ranging from 36 to 81; 43% were 65 or older. (“Median” refers to the middle value in a set of results.)
  • Most were women (63%) and the rest were men.
  • Most participants were Asian (70%) and 22% were White; 1.8% identified as Hispanic or Latino.
  • About one-third (33%) had cancer that had spread to the brain.
  • All had an EGFR mutation: 53% had exon 19 deletions, 34% had exon 21 L858R mutations, 28% had T790M mutations, and smaller numbers had other types.
  • All had already received treatments for their cancer, including EGFR-targeted therapy (84% had taken osimertinib), platinum-based chemotherapy, and/or immunotherapy (28% had received PD-1/PD-L1 inhibitors).

People in this group received Datroway as an infusion once every three weeks. They continued getting the treatment as long as the side effects were manageable. Treatment stopped if the cancer got worse or serious side effects happened. 

The main goal for this subgroup analysis was to see how well Datroway worked in people with EGFR-mutated NSCLC. Researchers measured this by looking at the overall response rate (ORR), which shows how many people had their tumors shrink or disappear on scans. They also tracked the duration of response (DOR), which is how long the tumors stayed smaller before growing again. 

The clinical trials found that Datroway helped shrink tumors in some people with EGFR-mutated NSCLC. Your results may be different from what was seen in studies.

The following results were seen in a subgroup of 114 people who received Datroway:

  • The overall response rate (ORR) was 45%, meaning almost half of people had their tumors shrink or disappear on scans.
  • 4.4% had a complete response, meaning they had no signs of cancer on imaging tests.
  • 40% had a partial response, meaning their tumors shrank but did not fully disappear.

The results also showed that many people had a lasting response to Datroway. Among those who had a response:

  • The median duration of response (DOR) was 6.5 months, meaning their tumors stayed smaller for 6.5 months before the tumors started growing again.
  • 47% of people had a response that lasted at least six months.
  • 18% had a response that lasted at least 12 months.

Note that ORR and DOR were assessed by independent reviewers who were not involved in treating the patients and evaluated the scans without knowing individual patient details.

Based on these results, the FDA granted accelerated approval to Datroway for certain adults with advanced, EGFR-mutated NSCLC. This early approval was based on how many people responded to Datroway and how long the responses lasted. But more studies are needed to confirm whether Datroway can help people live longer. If future studies confirm the benefit, full approval may be granted.

Here are some common side effects of Datroway and ways to prevent or manage them. Let your health care provider know if any side effects bother you or do not go away. 

Sore mouth. The most common side effect of Datroway is stomatitis, which is when you have mouth sores, pain, or inflammation inside the mouth. In studies, about 6 out of 10 people (63%) treated with Datroway had stomatitis, which usually started within the first few weeks of treatment. Most cases were mild to moderate, but a small number of people had severe symptoms.

To help prevent or manage stomatitis, your health care provider will give you a mouthwash that contains a steroid. Use it as directed. You may also be asked to hold ice chips or sip cold water during your infusion to help protect the inside of your mouth.

Let your care team know if you have any mouth pain, sores, or trouble eating or drinking. They may adjust your treatment or recommend other ways to ease your symptoms.

Eye problems. Datroway can cause side effects that affect your eyes. These may include dry eyes, eye irritation, blurry vision, or inflammation in different parts of the eye, such as the eyelids or cornea (the clear front part of the eye). In studies, about 1 in 3 people (36%) had some type of eye-related side effect while taking Datroway.

To help protect your eyes, your health care provider may recommend:

  • Using preservative-free lubricating eye drops several times a day
  • Avoiding contact lenses unless your eye doctor says it is safe
  • Getting your eyes checked by an eye specialist before starting treatment, once a year during treatment or anytime you notice new or worsening eye problems, and again at the end of treatment

Tell your care team right away if you notice any changes in your vision or have eye discomfort. They may refer you to an eye specialist and adjust your treatment plan if needed.

Infusion reactions. Datroway is given as an infusion into a vein. Some people may have reactions during an infusion that can be serious. If you have these reactions, your infusion may need to be paused, slowed, or stopped. Tell your health care provider right away if you have trouble breathing, chills, dizziness, flushing, or chest pain during your infusion. To help prevent infusion reactions, your health care provider may give you medicines before each infusion.

This is not a complete list of side effects. Datroway may cause other serious side effects. Your health care will monitor you during Datroway treatment and may recommend ways to prevent or manage side effects. Tell your health care provider about any side effects you have or if your symptoms feel worse than usual. If side effects are severe or serious, they might adjust your dose, pause treatment, or stop it altogether.

A cost assistance program is available from Daiichi-Sankyo, the manufacturer of Datroway. It may reduce the amount you pay. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured. Visit this website from the drugmaker for more information about Datroway costs and copay savings. 

 You can also contact the drugmaker at 877-437-7763 to connect with a representative for financial support information and other resources.