ROZLYTREK was studied in 92 people with ROS1+ mNSCLC across 3 clinical trials. These studies measured 2 things: how many people had their tumors shrink, and the length of time that response lasted. The trials did not compare ROZLYTREK to another medication.
15% (14 out of 92 people) had a complete response
and 59% (54 out of 92 people) had a partial response.
It is important to know that a complete response does not mean the cancer has been cured.
In the same clinical trials, 10 out of 92 people had ROS1+ mNSCLC that had spread to the brain (known as CNS metastases) and did not have prior radiation therapy for these tumors (within 2 months of starting ROZLYTREK).
Please note that these results were only observed in a limited number of patients.
*It is important to know that tumor shrinkage does not mean the cancer has been cured.
†Patients had not received radiation therapy to the brain within 2 months of treatment with ROZLYTREK.
CNS=central nervous system.
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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.
The approval of ROZLYTREK was based on a study that measured response to treatment and duration of response. Continued approval for this use may depend on the results of an ongoing study to confirm the benefit of ROZLYTREK for this use.
What is the most important information I should know about ROZLYTREK?
ROZLYTREK may cause serious side effects, including:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
Certain other medicines may affect how ROZLYTREK works causing side effects. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
These are not all the possible side effects of ROZLYTREK. For more information on ROZLYTREK’s risks and benefits, ask your healthcare provider or pharmacist.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
Please see additional Important Safety Information in the full Prescribing Information, including Patient Information.
Central nervous system, which includes the brain and spinal cord.
Cancer that develops in the colon, which is the longest part of the large intestine and/or the rectum (the last several inches of the large intestine before the anus).
The disappearance of all signs of cancer, such as tumors, in response to treatment. This does not mean the cancer has been cured.
Molecules within cells that carry genetic information.
A type of gene made by joining parts of 2 different genes. Fusion genes make fusion proteins, which can be the root cause of some kinds of cancer.
long QT syndrome
A condition where the heart beats fast and irregularly. Long QT syndrome might cause a person to faint or have a seizure. In some instances, the heart can beat out of control for so long that it may cause sudden death.
papillary thyroid cancer
The most common type of thyroid cancer.
The decrease in the size and spread of tumors or extent of cancer in the body in response to a given treatment.
A molecule that is needed for your body to function properly. Proteins are the basis of body structures, like skin and hair, and other substances in your body.
A rare cancer found in the tissues of the gland that makes saliva.
A cancer that begins in the bone and soft tissue.
secretory breast cancer
A rare type of breast cancer.
Cancer of the thyroid. The thyroid is an organ at the base of the throat. It makes hormones that help control heart rate, blood pressure, body temperature, and weight.
An NTRK gene fusion tells the body to make abnormal versions of TRK, or tropomyosin receptor kinase, fusion proteins. TRK fusion proteins are a family of several proteins that normally plays an important role in the nervous system. People with NTRK fusion-positive solid tumors have an abnormal version of TRK called a TRK fusion protein.
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