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Follicular Lymphoma (FOLL) : NCCN Guidelines For Non-Hodgkin's Lymphomas V.1.2017 - Update Meeting - 06/27/16 and 06/28/16
Follicular Lymphoma (FOLL) : NCCN Guidelines For Non-Hodgkin's Lymphomas V.1.2017 - Update Meeting - 06/27/16 and 06/28/16
FOLL-B
Internal request Based on the on the discussion of data from the multicenter phase II
Panel discussion to add a qualifier trial (noted in the reference below) that evaluated idelalisib in patients 11 7 8 1
statement for the use of idelalisib with patients with indolent NHL who had received extensive prior
as second-line and subsequent treatment, the panel consensus was to include the qualifier statement
therapy for FL. “refractory to both alkylator and rituximab” for the use of idelalisib as
second-line and subsequent therapy for FL, to be consistent with the
eligibility criteria that were used in the aforementioned trial.
Gopal A, Kahl B, De Vos S, et al. PI3Kδ inhibition by idelalisib in
patients with relapsed indolent lymphoma. N Engl J Med
2014;370:1008-1018.
NCCN Guidelines for Non-Hodgkin’s Lymphomas V.1.2017 – Update Meeting – 06/27/16 and 06/28/16
FOLL-B
External request Based on the submitted references and discussion, the panel
Submission from Genentech, inc consensus was to include bendamustine + obinutuzumab as an 22 1 3 1
to consider the overall survival option for second-line and subsequent therapy for FL. This was
results for the follicular lymphoma added as a category 2A recommendation.
patient population from the See submission for references.
GADOLIN study and the following
new FDA-approved indication for
obinutuzumab: obinutuzumab is
indicated in combination with
bendamustine followed by
obinutuzumab monotherapy, for
the treatment of patients with
follicular lymphoma who relapsed
after, or are refractory to, a
rituximab containing regimen.
FOLL-B
Internal request In the aforementioned GADOLIN study, patients with indolent NHL 9 14 2 2
Panel discussion to determine if refractory to rituximab were randomized to bendamustine plus
the data to support bendamustine obinutuzumab or bendamustine monotherapy. Non-progressing
+ obinutuzumab is category 1 patients in the bendamustine plus obinutuzumab group received
level evidence for second-line and obinutuzumab maintenance. Although bendamustine plus
subsequent therapy for FL. obinutuzumab followed by obinutuzumab maintenance had improved
efficacy over bendamustine monotherapy, based on the study design
(noted above), the panel consensus was that the available evidence
does not support the inclusion of bendamustine + obinutuzumab with
a category 1 recommendation.
FOLL-B
Internal request Based on the discussion for obinutuzumab maintenance for
Panel discussion to reassess the rituximab-refractory disease for second-line consolidation of FL, the 18 3 5 1
category designation for panel consensus vote resulted in a category change from a category
obinutuzumab maintenance for 2B to a category 2A recommendation.
rituximab-refractory disease for
second-line consolidation of FL.
NCCN Guidelines for Non-Hodgkin’s Lymphomas V.1.2017 – Update Meeting – 06/27/16 and 06/28/16
MANT-A
Internal request Based on the noted reference and discussion, the panel consensus
Institutional review comment to was to include lenalidomide + rituximab as a less aggressive induction 22 0 3 2
consider the inclusion of therapy option. This was added as a category 2A recommendation.
lenalidomide + rituximab as a Ruan J, Martin P, Shah B, et al. Lenalidomide plus rituximab as
less aggressive induction initial treatment for mantle-cell lymphoma. N Engl J Med
therapy option. 2015;373:1835-44.
MANT-A
Internal request Based on the noted reference and discussion, the panel consensus
Institutional review comment to was to include bendamustine, bortezomib and rituximab as a second- 13 5 7 2
consider the inclusion of line treatment option for patients with MCL. This was added as a
bendamustine, bortezomib and category 2B recommendation.
rituximab as a second-line Friedberg JW, Vose JM, Kelly JL, et al. The combination of
treatment option for patients with bendamustine, bortezomib, and rituximab for patients with
MCL. relapsed/refractory indolent and mantle cell non-Hodgkin
lymphoma. Blood 2011;117:2807-2812.
MANT-A
Internal request Based on the panel discussion regarding the limited data and activity 7 13 5 2
Institutional review comment to for fludarabine, cyclophosphamide ± rituximab for the second-line
reassess the inclusion of treatment of FL, the panel consensus vote resulted in the category
fludarabine, cyclophosphamide ± changing from a category 2A to a category 3 recommendation.
rituximab as a second-line
treatment option for patients with
MCL.
MANT-A Based on the panel discussion regarding the limited data and activity
Internal request for pentostatin, cyclophosphamide and rituximab for the second-line 3 15 5 4
Institutional review comment to treatment of FL, the panel consensus vote resulted in the category
reassess the inclusion of changing from a category 2A to a category 3 recommendation.
pentostatin, cyclophosphamide
and rituximab as a second-line
treatment option for patients with
MCL.
MANT-A Based on the panel discussion regarding the limited data and activity
Internal request for prednisone, etoposide, procarbazine, cyclophosphamide ± 6 12 4 5
Institutional review comment to rituximab for the second-line treatment of FL, the panel consensus
reassess the inclusion of vote resulted in the category changing from a category 2A to a
prednisone, etoposide, category 3 recommendation.
procarbazine, cyclophosphamide
± rituximab as a second-line
treatment option for patients with
MCL.
MANT-A Based on the noted reference and discussion, the panel consensus
Internal request was to include venetoclax as a second-line treatment option for 23 0 2 4
Discussion comment to consider patients with MCL. This was added as a category 2A recommendation.
the inclusion of venetoclax as a Gerecitano JF et al. A Phase 1 study of venetoclax (ABT-199 /
second-line treatment option for GDC-0199) monotherapy in patients with relapsed/refractory Non-
patients with MCL. Hodgkin Lymphoma. Blood 2015;126:Abstract 254
NCCN Guidelines for Non-Hodgkin’s Lymphomas V.1.2017 – Update Meeting – 06/27/16 and 06/28/16
Supportive Care
Guideline Page Institution Vote
Panel Discussion/References
and Request YES NO ABSTAIN ABSENT
NHODG-B
External request 17 2 1 7
Submission request from Based on the of current data, the panel consensus was that the dose of
Sanofi to: rasburicase as listed in the guidelines is safe and effective. Therefore,
Under the “First-line and at the panel voted that the information regarding rasburicase dose should
retreatment for remain the same.
hyperuricemia” bullet,
change wording to “For
inpatient treatment, one
dose of rasburicase is
frequently adequate.
Doses of 3-6 mg are
usually effective. Redosing
should be individualized.”
NCCN Guidelines for Non-Hodgkin’s Lymphomas V.1.2017 – Update Meeting – 06/27/16 and 06/28/16