The ALK gene makes an ALK protein, which may be involved in cell growth. Mutations of the ALK gene and protein have been found in certain types of cancer, including non-small cell lung cancer.
ALK inhibitors are medicines that bind to and stop the ALK fusion protein. This may help prevent the growth and spread of tumor cells.
ALK (anaplastic lymphoma kinase)-positive metastatic non-small cell lung cancer is a type of lung cancer that has spread to other places in the body, involving the ALK gene.
The central nervous system includes the brain and the spinal cord.
The disappearance of all signs of cancer, such as tumors, in response to treatment. This does not mean the cancer has been cured.
The amount of time from when tumors first start to shrink in response to a given treatment to the time when tumors begin to grow again.
An assessment of study results that was not specifically designed to find differences between two treatments in a study.
The Food and Drug Administration, or FDA, is a US federal agency whose mission is to protect public health.
The median is the middle value, or number, in a set of measurements when arranged from least to greatest.
The spread of cancer from the place where it started to other places in the body.
The length of time from the date of diagnosis or the start of treatment for a disease that people diagnosed with the disease are still alive.
The length of time during and after cancer treatment when a patient lives with the disease without it getting worse.
The decrease in the size and spread of tumors in response to a given treatment.
A molecule that is needed for your body to function properly. Proteins are the basis of cells in your body, including ALK.
A type of research study, or clinical trial, that tests how well a new medicine works in people. Studies can test new methods of screening, prevention, diagnosis, or treatment of a disease
Criteria | ALECENSA dose modification |
---|---|
ALT or AST elevation of >5X ULN with total bilirubin ≤2X ULN | Temporarily withhold until recovery to baseline or to ≤3X ULN, then resume at reduced dose. See dose reduction schedule. |
ALT or AST elevation >3X ULN with total bilirubin elevation >2X ULN in the absence of cholestasis or hemolysis | Permanently discontinue ALECENSA. |
Total bilirubin elevation >3X ULN | Temporarily withhold until recovery to baseline or to ≤1.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Any grade treatment-related ILD/pneumonitis | Permanently discontinue ALECENSA. |
Grade 3 renal impairment | Temporarily withhold until serum creatinine recovers to ≤1.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Grade 4 renal impairment | Permanently discontinue ALECENSA. |
Symptomatic bradycardia | Withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume ALECENSA at previous dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If no contributing concomitant medication is identified, or if contributing concomitant medications are not discontinued or dose modified, resume ALECENSA at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. See dose reduction schedule. |
Bradycardiaa (life-threatening consequences, urgent intervention indicated) | Permanently discontinue ALECENSA if no contributing concomitant medication is identified. If contributing concomitant medication is identified and discontinued, or its dose is adjusted, resume ALECENSA at reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm, with frequent monitoring as clinically indicated. Permanently discontinue ALECENSA in case of recurrence. See dose reduction schedule. |
CPK elevation of >5X ULN | Temporarily withhold until recovery to baseline or to ≤2.5X ULN, then resume at same dose. |
CPK elevation >10X ULN or second occurrence of CPK elevation of >5X ULN | Temporarily withhold until recovery to baseline or to ≤2.5X ULN, then resume at reduced dose. See dose reduction schedule. |
Hemolytic anemia | Withhold ALECENSA if hemolytic anemia is suspected. Upon resolution, resume at reduced dose or permanently discontinue. See dose reduction schedule. |
aHeart rate <60 bpm.
ALT=alanine transaminase; AST=aspartate transaminase; bpm=beats per minute; CPK=creatine phosphokinase; ILD=interstitial lung disease; ULN=upper limit of normal.
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