NCCN Guidelines for Gastric Cancer V.1.
2023 Follow-up on 01/27/23
Guideline Page
and Request
GAST-B (5 of 6)
External request
Submission from Eli Lilly and Company (09/21/22)
requesting the inclusion of selpercatinib as a
recommended therapy option for the treatment of
patients with rearranged during transfection (RET)
fusion-positive gastric cancer and appropriate RET
gene fusion testing in the NCCN Guidelines in the
following section:
Principles of Pathologic Review and Biomarker
Testing | Next-Generation Sequencing (NGS)
• Add selpercatinib for RET gene fusion-positive
solid tumors
GAST-F (5 of 17)
External Request
Submission from Eli Lilly and Company (09/21/22)
requesting the inclusion of selpercatinib as a
recommended therapy option for the treatment of
patients with rearranged during transfection (RET)
fusion-positive gastric cancer and appropriate RET
gene fusion testing in the NCCN Guidelines in the
following section:
Under “Useful in certain circumstances,” add
selpercatinib for RET gene fusion-positive tumors.
Panel Discussion/References Vote
YES NO ABSTAIN ABSENT
Based on the review of the data and discussion, the panel 19 1 7 6
consensus was to update the Next-Generation Sequencing
section of the Principle of Pathologic Review and
Biomarker Testing to include selpercatinib for RET fusion-
positive tumors as follows:
“…and entrectinib/larotrectinib, selpercatinib, and
dabrafenib/trametinib have been approved by the FDA for
use in gastric cancer. Trastuzumab is based on testing for
HER2 overexpression. Pembrolizumab/nivolumab are
based on testing for MSI by PCR or NGS/MMR by IHC,
PD-L1 immunohistochemical expression, or high tumor
mutational burden (TMB) by NGS. The FDA granted
approval for the use of select TRK inhibitors for NTRK
gene fusion-positive solid tumors, and selpercatinib for
RET gene fusion-positive tumors. Dabrafenib/trametinib
have been approved for tumors with BRAF V600E
mutations. When limited tissue is available for testing, or
the patient is unable to undergo a traditional biopsy,
sequential testing of single biomarkers or use of limited
molecular diagnostic panels may quickly exhaust the
sample. In these scenarios, comprehensive genomic
profiling via a validated NGS assay performed in a CLIA-
approved laboratory may be used for the identification of
HER2 amplification, MSI status, MMR deficiency, TMB,
and NTRK gene fusions, RET gene fusions, and BRAF
V600E mutations. The use of IHC/ISH/targeted PCR
should be…”
See submission for references.
Based on the review of the data, the panel consensus was 17 1 9 6
to include selpercatinib as a second-line or subsequent
therapy option for RET fusion-positive esophageal and
esophagogastric junction cancers. This is a category 2A,
[useful in certain circumstances] recommendation.
See submission for references.
NCCN Guidelines for Gastric Cancer V.1.2023 Follow-up on 01/27/23
GAST-F (14 of 17)
External Request
Submission from Eli Lilly and Company (09/21/22)
requesting the inclusion of selpercatinib as a
recommended therapy option for the treatment of
patients with rearranged during transfection (RET)
fusion-positive esophageal and esophagogastric
junction cancers and appropriate RET gene fusion
testing in the NCCN Guidelines in the following
section:
• Principles of Systemic Therapy – Regimens
and Dosing Schedules: Under “Useful in
certain circumstances,” add selpercatinib for
RET gene fusion-positive tumors.
Based on the review of the data, the panel consensus was 14 1 12 6
to include the dosing schedule for selpercatinib as a
second-line or subsequent therapy option for RET fusion-
positive esophageal and esophagogastric junction cancers.
This is a category 2A, [useful in certain circumstances]
recommendation as follows:
• Patients ≥50 kg: 160 mg PO twice daily
• Patients <50 kg: 120 mg PO twice daily
See submission for references.