TreatmentNTRK gene fusion-positive solid tumors,ROS1-positive NSCLC
ManufacturerPHOKHAM 2 PHARMACEUTICAL,Laos PDR
Entrectinib, sold under the brand name Phoentre, Rozlytrek, is an anti-cancer medication used to treat ROS1-positive non-small cell lung cancer and NTRK fusion-positive solid tumors. It is a selective tyrosine kinase inhibitor (TKI), of the tropomyosin receptor kinases (TRK) A, B and C, C-ros oncogene 1 (ROS1) and anaplastic lymphoma kinase (ALK).
The most common side effects include tiredness, constipation, dysgeusia (taste disturbances), edema (swelling with fluid retention), dizziness, diarrhea, nausea (feeling sick), dysesthesia (unpleasant and abnormal feeling when touched), dyspnea (difficulty breathing), anemia (low red blood cell count), increased weight, increased blood creatinine (possible sign of kidney problems), pain, cognitive disorders (problems with ability to think, learn and remember), vomiting, cough, and fever.
It was approved for medical use in the United States in August 2019, in Australia in May 2020,and in the European Union in July 2020.
In the US, entrectinib is indicated to treat patients whose cancers are ROS1-positive (have a specific genetic feature (biomarker)).It is to be used in those with solid tumors that:
are caused by certain abnormal neurotrophic tyrosine receptor kinase (NTRK) genes, and
have spread or if surgery to remove their cancer is likely to cause severe complications, and
there is no acceptable treatment, or the cancer grew or spread on other treatment
Entrectinib is not approved for use in those less than twelve years of age.
In the European Union, entrectinib as monotherapy is indicated for the treatment of adults and adolescents twelve years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion,
who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and
who have not received a prior NTRK inhibitor
who have no satisfactory treatment options.
It is also indicated for the treatment of adults with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
Why is this medication prescribed?
Entrectinib is used to treat a certain type of non-small cell lung cancer (NSCLC) in adults that has spread to other parts of the body. It is also used to treat certain types of solid tumors in adults and children 12 years of age and older that cannot be treated by surgery or that has spread to other parts of the body and that worsened after treatment with other chemotherapy medications. Entrectinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.
How should this medicine be used?
Entrectinib comes as a capsule to take by mouth. It is usually taken with or without food once daily. Take entrectinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take entrectinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole; do not open, chew, or crush them.
If you vomit immediately after you take entrectinib, take another dose as soon as possible.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What side effects can this medication cause?
Entrectinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
cough, fever, or other signs of infection
muscle or joint pain
difficulty falling or staying asleep.