NCCN Guidelines for Ampullary Adenocarcinoma V.2.
2022 – Interim on 10/14/2022
Guideline Page
and Request
AMP-E 3 of 6
Internal request:
In response to the FDA approval of dabrafenib +
trametinib for the treatment of unresectable or
metastatic solid tumors with BRAF V600E mutation
who have progressed following prior treatment and
have no satisfactory alternative treatment options:
1. The panel requested the addition of dabrafenib
+ trametinib as a first-line therapy option for
metastatic ampullary adenocarcinoma in
patients with Good PS and a BRAF V600E
mutation.
2. The panel requested the addition of dabrafenib
+ trametinib as a first-line therapy option for
metastatic ampullary adenocarcinoma in
patients with Poor PS and a BRAF V600E
mutation.
AMP-E 4 of 6
Internal request:
In response to the FDA approval of dabrafenib +
trametinib for the treatment of unresectable or
metastatic solid tumors with BRAF V600E mutation
who have progressed following prior treatment and
have no satisfactory alternative treatment options:
1. The panel requested the addition of dabrafenib
+ trametinib as a subsequent therapy option for
metastatic ampullary adenocarcinoma in
patients with Good PS and a BRAF V600E
mutation.
Institution Vote
Panel Discussion/References
YES NO ABSTAIN ABSENT
1. Based on the review of the data in the noted 7 12 7 6
references, and the recent FDA approval, the
panel consensus was to include dabrafenib +
trametinib as a first-line therapy option for
metastatic ampullary adenocarcinoma in
patients with Good PS and a BRAF V600E
mutation. This is a category 3, useful in
certain circumstances recommendation.
2. Based on the review of the data in the noted 10 9 7 6
references, and the recent FDA approval, the
panel consensus was to include dabrafenib +
trametinib as a first-line therapy option for
metastatic ampullary adenocarcinoma in
patients with Poor PS and a BRAF V600E
mutation. This is a category 2B, useful in
certain circumstances recommendation.
1. Based on the review of the data in the noted 19 1 6 6
references, and the recent FDA approval, the
panel consensus was to include dabrafenib +
trametinib as a subsequent therapy option for
metastatic ampullary adenocarcinoma in
patients with Good PS and a BRAF V600E
NCCN Guidelines for Ampullary Adenocarcinoma V.2.2022 – Interim on 10/14/2022
2. The panel requested the addition of dabrafenib
+ trametinib as a subsequent therapy option for
metastatic ampullary adenocarcinoma in
patients with Poor PS and a BRAF V600E
mutation.
mutation. This is a category 2A, other
recommended recommendation.
2. Based on the review of the data in the noted 18 2 6 6
references, and the recent FDA approval, the
panel consensus was to include dabrafenib +
trametinib as a subsequent therapy option for
metastatic ampullary adenocarcinoma in
patients with Poor PS and a BRAF V600E
mutation. This is a category 2A, useful in
certain circumstances recommendation.