(BPT) - A new medicine approved by the U.S. Food and Drug Administration (FDA) is part of an exciting evolution in the way doctors treat cancer. Traditionally, cancer is treated based on where it starts in the body, but now doctors can treat some cancers based on specific genetic rearrangements, or biomarkers, that cause the cancer to grow – regardless of the organ or tissue from which it originates. This is known as tumor-agnostic treatment.1
Biomarker testing is different from genetic testing, which looks for traits inherited from your mother or father found in every cell of your body and then determines if you have higher risk of developing cancer or other diseases. Biomarker testing, however, is done after a cancer diagnosis to find genetic changes that occur in the tumor itself and can help doctors make treatment decisions.2,3
For example, biomarker testing can identify a genetic rearrangement called neurotrophic tyrosine receptor kinase (NTRK) gene fusions, which can be found in certain advanced solid tumors, including common cancers like breast and colorectal cancers as well as rare tumor types. Rates of NTRK vary based on the type of cancer, occurring in less than 1 percent of colorectal cancer cases and up to 100 percent of some rare salivary gland cancers.4 If a person’s tumor is found to be NTRK gene fusion-positive, they may be eligible to receive a targeted medicine such as Rozlytrek™ (entrectinib), which was recently approved by the FDA.
“Rozlytrek is the most recent advance in tumor-agnostic medicine, which is providing personalized treatment options that target the unique genetic makeup of each person’s cancer,” said Dr. Robert Doebele, Associate Professor of Medicine, Division of Medical Oncology, University of Colorado. “Through biomarker testing, we can potentially unlock information that can have an important impact on determining their options for treatment.”
Here is what you need to know about biomarker testing:
What is biomarker testing?
Biomarker testing identifies changes within your cancer cells that cause your tumor to grow. In addition to NTRK, there are other biomarkers, such as ROS1, ALK, BRAF, EGFR, HER2, PD-L1 and many more, that testing may reveal and that can be matched to different medicines. Tests either search for biomarkers one at a time or can identify a wide range at once.
Who should have biomarker testing?
Anyone diagnosed with an advanced cancer should ask their doctor about biomarker testing. It is the only way to identify if you could potentially benefit from certain medicines, so it is a critical part of the conversation that takes place with your care team to find the right treatment.
It’s important to note that not everyone who gets tested will have tumors that have an identifiable biomarker that can be targeted with a medicine. However, the test may reveal potential treatment options that are available based on your specific cancer.
When should I have a conversation about biomarker testing with my doctor?
It’s best to talk to your doctor about biomarker testing as soon as you learn you have advanced cancer. If your doctor thinks testing is right for you, testing will be done as soon as possible following your diagnosis and prior to treatment.
Where does biomarker testing take place?
Depending on the location of your tumor and type of test, biomarker testing can be done at a doctor’s office, hospital or testing facility.
How is biomarker testing done?
A healthcare professional, such as your doctor, will collect a small sample from your tumor and send the sample to a lab. A laboratory technician will scan your tumor’s genetic information to find any biomarkers and communicate the findings to your doctor, who will share the results with you and help you to understand what they mean for decisions around your treatment.
Rozlytrek™ U.S. Indication (pronounced roz lye' trek)
Rozlytrek is a prescription medicine used to treat:
It is not known if Rozlytrek is safe and effective for use in children less than 12 years of age.
Rozlytrek was approved in NTRK gene fusion-positive solid tumors through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm benefit of Rozlytrek for this use.
Important Safety Information
Rozlytrek may cause serious side effects, including:
Before taking Rozlytrek, patients should tell their healthcare provider about all their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
Certain other medicines may affect how Rozlytrek works causing side effects. Patients should know the medicines they take. Patients should keep a list of them to show to their healthcare provider and pharmacist when they get a new medicine.
The most common side effects of Rozlytrek include:
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These are not all the possible side effects of Rozlytrek. For more information, patients should ask their healthcare provider or pharmacist.
Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please see http://www.Rozlytrek.com for the full Prescribing Information, including Patient Information.
References
1 Flaherty KT, Le DT, Lemery S. Tissue-Agnostic Drug Development. Am Soc Clin Oncol Educ Book. 2017;37:222-230. doi: 10.14694/EDBK_173855. Accessed April 2019.
2 National Comprehensive Cancer Network; Biomarker Testing; [internet] https://www.nccn.org/patients/resources/life_with_cancer/treatment/biomarker_testing.aspx. Accessed May 2019.
3 National Institute of Health, Genetics Home Reference; What is Genetic Testing; [internet] https://ghr.nlm.nih.gov/primer/testing/genetictesting. Accessed May 2019.
4 Amatu A, Sartore-Bianchi A, Siena S. ESMO Open. 2016;1(2):e000023. PMID: 27843590