Gene:
FIP1L1
FIP1 like 1 (S. cerevisiae)

PharmGKB contains no dosing guidelines for this . To report known genotype-based dosing guidelines, or if you are interested in developing guidelines, click here.

PharmGKB annotates drug labels containing pharmacogenetic information approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency, Japan (PMDA). PharmGKB annotations provide a brief summary of the PGx in the label, an excerpt from the label and a downloadable highlighted label PDF file. A list of genes and phenotypes found within the label is mapped to label section headers and listed at the end of each annotation. PharmGKB also attempts to interpret the level of action implied in each label with the "PGx Level" tag.

Sources:

  • FDA Information is gathered from the FDA's "Table of Pharmacogenomic Biomarkers in Drug Labels" and from FDA-approved labels brought to our attention. Please note that drugs may be removed from or added to the FDA's Table without our knowledge. We periodically check the Table for changes and update PharmGKB accordingly. Drugs listed on the Table to our knowledge are tagged with the Biomarker icon. A drug label that has been removed from the Table will not have the Biomarker icon but will continue to have an annotation on PharmGKB stating the label has been removed from the FDA's Table. We acquire label PDF files from DailyMed.
  • EMA European Public Assessment Reports (EPARs) that contain PGx information were identified from [Article:24433361] and also by searching for drugs for which we have PGx-containing FDA drug labels.

We welcome any information regarding drug labels containing PGx information approved by the FDA, EMA, PMDA or other Medicine Agencies around the world - please contact feedback.



last updated 10/25/2013

European Medicines Agency (EMA) Label for imatinib and ABL1, BCR, FIP1L1, KIT, PDGFRB

Genetic testing required

Summary

The EMA European Public Assessment Report (EPAR) for imatinib (Glivec) contains pharmacogenetic information regarding the indication of the drug in patients with tumors positive for biomarkers including KIT (CD117), BCR-ABL (Philadelphia chromosome), PDGFR and FIP1L1-PDGFRalpha rearrangements.

Annotation

Excerpt from the imatinib (Glivec) EPAR:

Glivec is indicated for the treatment of

  • adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
  • adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
  • adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
  • adult patients with relapsed or refractory Ph+ ALL as monotherapy.
  • adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
  • adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement.

Glivec is indicated for

  • the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
  • the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.

This information is highlighted in the following sections:
Therapeutic indications, posology and method of administration, pharmacodynamic properties, package leaflet: information for the user.

The label also states that caution be taken when imatinib is taken concomittantly with CYP3A4 inhibitors and CYP3A4 inducers should be avoided.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the imatinib EMA drug label.

*Disclaimer: The contents of this page have not been endorsed by the EMA and are the sole responsibility of PharmGKB.


Pharmaceuticals and Medical Devices Agency, Japan (PMDA) Label for imatinib and ABL1, BCR, FIP1L1, KIT, PDGFRA

Genetic testing required

Summary

The PMDA package insert for imatinib contains pharmacogenetic information regarding the indication of the drug in patients with the Kit (CD117)-positive tumors, hypereosinophilic syndrome and/or chronic eosinophilic leukemia with FIP1L1-PDGFR a rearrangement, or Philadelphia chromosome positive (BCR-ABL) acute lymphoblastic leukemia.

Annotation

Please note that the information contained within this drug label annotation is sourced from Shimazawa and Ikeda (2013), whose paper provided a translation of the pharmacogenetic information contained in the PMDA package insert.

Excerpts from the package insert for imatinib:

[Indications]: Kit (CD117) positive gastrointestinal stromal tumors. Precautions for indications: Kit (CD117) immunohistochemistry positive should be detected in patients with gastrointestinal stromal tumors. Assessment for Kit (CD117) positive should be performed by a pathologist with sufficient experience or in a specialized laboratory.

[Indications]: Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRa rearrangement. Precautions for indications: FIP1L1-PDGFRa rearrangement should be detected in chromosomal or genetic test in patients with HES or CEL.

[Indications]: Philadelphia chromosome positive acute lymphoblastic leukaemia. Precautions for indications: Philadelphia chromosome positive should be detected in chromosomal or genetic test in patients with acute lymphoblastic leukaemia.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the imatinib package insert (in Japanese).

*Disclaimer: The contents of this page have not been endorsed by the PMDA and are the sole responsibility of PharmGKB.

Genes and/or phenotypes found in this label

  • ABL1
    • Indications & usage section, other
    • source: Pharmaceuticals and Medical Devices Agency, Japan (PMDA) Label
  • BCR
    • Indications & usage section, other
    • source: Pharmaceuticals and Medical Devices Agency, Japan (PMDA) Label
  • FIP1L1
    • Indications & usage section, other
    • source: Pharmaceuticals and Medical Devices Agency, Japan (PMDA) Label
  • KIT
    • Indications & usage section, other
    • source: Pharmaceuticals and Medical Devices Agency, Japan (PMDA) Label
  • PDGFRA
    • Indications & usage section, other
    • source: Pharmaceuticals and Medical Devices Agency, Japan (PMDA) Label

PharmGKB contains no Clinical Variants that meet the highest level of criteria.

Disclaimer: The PharmGKB's clinical annotations reflect expert consensus based on clinical evidence and peer-reviewed literature available at the time they are written and are intended only to assist clinicians in decision-making and to identify questions for further research. New evidence may have emerged since the time an annotation was submitted to the PharmGKB. The annotations are limited in scope and are not applicable to interventions or diseases that are not specifically identified.

The annotations do not account for individual variations among patients, and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It remains the responsibility of the health-care provider to determine the best course of treatment for a patient. Adherence to any guideline is voluntary, with the ultimate determination regarding its application to be made solely by the clinician and the patient. PharmGKB assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of the PharmGKB clinical annotations, or for any errors or omissions.

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This is a non-comprehensive list of genetic tests with pharmacogenetics relevance, typically submitted by the manufacturer and manually curated by PharmGKB. The information listed is provided for educational purposes only and does not constitute an endorsement of any listed test or manufacturer.

A more complete listing of genetic tests is found at the Genetic Testing Registry (GTR).

PGx Test Variants Assayed Related Drugs?

Overview

Alternate Names:  FIP1 like 1 (S. cerevisiae)
Alternate Symbols:  DKFZp586K0717; FIP1
PharmGKB Accession Id: PA134875694

Details

Cytogenetic Location: chr4 : q12 - q12
GP mRNA Boundary: chr4 : 54243820 - 54326103
GP Gene Boundary: chr4 : 54233820 - 54329103
Strand: plus
The mRNA boundaries are calculated using the gene's default feature set from NCBI, mapped onto the UCSC Golden Path. PharmGKB sets gene boundaries by expanding the mRNA boundaries by no less than 10,000 bases upstream (5') and 3,000 bases downstream (3') to allow for potential regulatory regions.
No related genes are available

Curated Information ?

Evidence Drug
No Dosing Guideline available DL No Clinical Annotation available No Variant Annotation available No VIP available No VIP available
imatinib
No related diseases are available

LinkOuts

Comparative Toxicogenomics Database:
81608
ModBase:
Q6UN15
HumanCyc Gene:
HS07234
HGNC:
19124

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