NCCN Guidelines for Gastrointestinal Stromal Tumors (GIST) V.1.

2023 – Annual on 02/03/23

Guideline Page Institution Vote

Panel Discussion/References
and Request YES NO ABSTAIN ABSENT
GIST-2 Based on a review of the data and discussion, the 14 3 8 7
Internal request: panel consensus supported the inclusion of
observation as a neoadjuvant option for resectable
Consider adding “observation” as a neoadjuvant option GIST with significant morbidity that are SDH-
for resectable GIST with significant morbidity that are deficient. This is a category 2B recommendation.
SDH-deficient.
GIST-E, 2 Based on a review of the data and discussion, the 12 2 11 7
External request: panel consensus supported the inclusion of ponatinib
for additional treatment options after progression on
Submission from Takeda Oncology (4/8/22) to consider approved therapies with the suggested footnote. This
the following: is a category 2A, useful in certain circumstances
• Add ponatinib for additional options after recommendation.
progression on approved therapies
• Add the following footnote: Ponatinib
demonstrated activity in advanced GIST,
particularly in patients with KIT ex11-mutant
disease.

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NCCN Guidelines for Gastrointestinal Stromal Tumors (GIST) V.1.2023 – Annual on 02/03/23
GIST-E, 2
External request:
Submission from Deciphera Pharmaceuticals (4/13/22
and 8/11/22) to consider inclusion of ripretinib as a
second line (2L) treatment option in patients with
unresectable, progressive, or metastatic GIST based
on the results from the Phase 3 INTRIGUE study.
GIST-E, 2
Internal request:
Consider adding the combination of imatinib and
binimetinib for the treatment of advanced SDH deficient
GIST.
GIST-E, 2
Internal request:
Consider adding sunitinib, regorafenib, and pazopanib
be included as treatment options for SDH deficient
GIST under useful in certain circumstances, for
unresectable, progressive or metastatic disease.
Based on a review of the data and discussion, the 15 2 8 7
panel consensus did not support the inclusion of
ripretinib as a second-line treatment option in patients
with unresectable, progressive, or metastatic GIST
based on the results fro the Phase 3 INTRIGUE
study.
However, the panel supported adding the following:
for second-line therapy for unresectable, progressive,
or metastatic disease, under “preferred regimen” “For
patients intolerant to second-line sunitinib, consider
changing to ripretinib 150 mg daily”, with the following
footnote, Ripretinib is FDA-approved for the
treatment of adult patients with advanced GIST who
have received prior treatment with 3 or more kinase
inhibitors, including imatinib.
Based on a review of the data and discussion, the 14 3 8 7
panel consensus supported the inclusion of imatinib
and binimetinib for the treatment of advanced SDH
deficient GIST. This is a category 2B, useful in
certain circumstances recommendation.
Based on a review of the data and discussion, the 19 1 5 7
panel consensus supported the inclusion of sunitinib,
regorafenib, and pazopanib as treatment options for
SDH deficient GIST. This is a category 2A, useful in
certain circumstances recommendation.