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This site is intended for US residents 18 years of age or older.

Results with DATROWAY

Clinical trial results

Lung cancer can be categorized by the way it spreads through the body: it can be locally advanced (spread to areas outside of the lung) or it can be metastatic (spread to other parts of the body). DATROWAY was studied in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) NSCLC is the most common type of lung cancer. It develops when normal cells in your lungs change and grow out of control, forming a tumor. that has certain mutations in a gene called epidermal growth factor receptor (EGFR)EGFR is a protein located on the surface of cells that helps them grow. A mutation in the gene that codes for the EGFR protein can make cells grow too much, which can cause cancer. . The clinical trials included adults who received prior EGFR-directed medicine and platinum-based chemotherapy. Common platinum-based chemotherapy drugs include cisplatin and carboplatin.

About the trials

DATROWAY was studied in two trials in patients with lung cancer. Only some of those patients in each trial had an EGFR mutation. Researchers studied the results in those patients with an EGFR mutation in both trials who took DATROWAY. They were studied as a group because their results represent a portion of all of the patients studied in each trial. The results don't represent all the patients in each trial.

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The trials were held at multiple research sites
114 people studied
This analysis and FDA-approval was based on 114 people who had an EGFR mutation
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Everyone had received prior treatments including an EGFR-directed medicine and platinum-based chemotherapy
36-81 age range
In the clinical trials, the median age was 63 years. A median is the middle number in a set of numbers

As you look through the results for DATROWAY, here are important points to note:

  • The trials were open label, meaning that both the people being treated and trial investigators knew which treatment was received. Therefore, the results could have been influenced by people switching to another treatment, leaving the study, or other factors
  • There were 2 clinical trials. One of them was single-arm, which means that everyone enrolled in the trial received DATROWAY. In that trial, DATROWAY was not compared to another medicine. In the other trial, DATROWAY was compared against docetaxel
  • The results below combine information from a group of patients in these 2 clinical trials and should be discussed with your doctor

Results with DATROWAY

Please remember that the results you will see are from clinical trials, and each person’s experience may differ. Speak with your doctor about what you may expect on DATROWAY treatment. DATROWAY was FDA-approved for this use based on clinical trials that measured how many patients responded and how long they responded. DATROWAY is still being studied to confirm these results.

Overall response rate (tumor shrinking) results

This is the percentage of people who had a partial or complete response to therapy. A complete response means the tumor could not be seen on imaging tests. A partial response means the tumor shrank by at least 30%.

How many people had their tumors shrink

Blue illustration of tumor shrinking

45%*of people had their tumors shrink with DATROWAY

*51 of 114 people studied.

  • 40% of people (46 out of 114) had a partial response, meaning their tumor shrank by at least 30%
  • 4.4% of people (5 out of 114) had a complete response, meaning their tumor could not be seen on imaging tests

Median duration of response

Median duration of response is the length of time half of the people who responded to DATROWAY (partial or complete) continued to respond after the first response was seen. This means the length of time people’s tumors continued to respond to treatment without growing or spreading. This was studied in 51 patients with an EGFR mutation who responded to DATROWAY.

How long people continued to respond to treatment

Illustration of a calendar that reads "6.5 MONTHS."

Median duration of response

Illustration of a calendar that reads "≥6 MONTHS."

47% of patients continued to respond

Illustration of a calendar that reads "≥12 MONTHS."

18% of patients continued to respond

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Looking for more information?

Download this brochure to learn more about DATROWAY.

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Frequently asked questions

Q: How do I know if I have an EGFR mutation?

Your doctor may have done biomarker testing to see if your lung cancer cells have the EGFR mutation or other biomarkers that helped your cancer grow. To test for biomarkers, your doctor may do a tissue biopsy, which tests a sample of tumor tissue in a lab, or a liquid biopsy, which tests a sample of your blood.

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Learn about the possible side effects of DATROWAY

Possible Side Effects