Panel Discussion/References

Transcription

1 Follicular Lymphoma (FOLL) Panel discussion to reassess the category designation for lenalidomide + rituximab as a firstline therapy for FL. Panel discussion to reassess the inclusion of radioimmunotherapy as first-line consolidation or extended dosing for FL. Based on the discussion regarding the data in the noted references for lenalidomide + rituximab as a first-line therapy for FL, the panel consensus vote resulted in a category change from a category 3 to a category 2B recommendation. Martin P, Jung S-H, Johnson JL, et al. CALGB (Alliance): A phase II trial of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma [abstract]. J Clin Oncol 2014;32:Abstract Fowler N, Davis R, Rawal S, et al. Safety and activity of lenalidomide and rituximab in untreated indolent lymphoma: an open-label, phase 2 trial. The Lancet Oncology 2014;15: Based on the panel discussion regarding the long-term toxicity associated with radioimmunotherapy and superiority of maintenance rituximab for the treatment of FL, the panel consensus vote resulted in the radioimmunotherapy category changing from a category 2A to a category 2B recommendation. YES NO ABSTAIN ABSENT Panel discussion to add a qualifier statement for the use of idelalisib as second-line and subsequent therapy for FL. Based on the on the discussion of data from the multicenter phase II trial (noted in the reference below) that evaluated idelalisib in patients with patients with indolent NHL who had received extensive prior treatment, the panel consensus was to include the qualifier statement 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:

2 External request Submission from Genentech, inc to consider the overall survival results for the follicular lymphoma patient population from the 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. Based on the submitted references and discussion, the panel consensus was to include bendamustine + obinutuzumab as an option for second-line and subsequent therapy for FL. This was added as a category 2A recommendation. See submission for references Panel discussion to determine if the data to support bendamustine + obinutuzumab is category 1 level evidence for second-line and subsequent therapy for FL. In the aforementioned GADOLIN study, patients with indolent NHL refractory to rituximab were randomized to bendamustine plus obinutuzumab or bendamustine monotherapy. Non-progressing patients in the bendamustine plus obinutuzumab group received obinutuzumab maintenance. Although bendamustine plus 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 Sehn LH, Chua NS, Mayer J, et al. GADOLIN: Primary results from a phase III study of obinutuzumab plus bendamustine compared with bendamustine alone in patients with rituximabrefractory indolent non-hodgkin lymphoma [abstract]. J Clin Oncol 2015;33(15_ suppl):abstract LBA8502. Panel discussion to reassess the category designation for obinutuzumab maintenance for rituximab-refractory disease for second-line consolidation of FL. Based on the discussion for obinutuzumab maintenance for rituximab-refractory disease for second-line consolidation of FL, the panel consensus vote resulted in a category change from a category 2B to a category 2A recommendation

3 Mantle Cell Lymphoma (MANT) consider the inclusion of lenalidomide + rituximab as a less aggressive induction therapy option. Based on the noted reference and discussion, the panel consensus was to include lenalidomide + rituximab as a less aggressive induction therapy option. This was added as a category 2A recommendation. Ruan J, Martin P, Shah B, et al. Lenalidomide plus rituximab as initial treatment for mantle-cell lymphoma. N Engl J Med 2015;373: YES NO ABSTAIN ABSENT consider the inclusion of bendamustine, bortezomib and rituximab as a second-line fludarabine, cyclophosphamide ± rituximab as a second-line fludarabine, cyclophosphamide, mitoxantrone, and rituximab as a second-line treatment option for patients with Based on the noted reference and discussion, the panel consensus was to include bendamustine, bortezomib and rituximab as a secondline This was added as a category 2B recommendation. Friedberg JW, Vose JM, Kelly JL, et al. The combination of bendamustine, bortezomib, and rituximab for patients with relapsed/refractory indolent and mantle cell non-hodgkin lymphoma. Blood 2011;117: Based on the panel discussion regarding the limited data and activity for fludarabine, cyclophosphamide ± rituximab for the second-line treatment of FL, the panel consensus vote resulted in the category changing from a category 2A to a category 3 recommendation. The panel discussion and consensus was that fludarabine, cyclophosphamide, mitoxantrone, and rituximab should be removed as a second-line treatment option for MCL due to limited clinical use and activity

4 fludarabine, mitoxantrone and rituximab as a second-line pentostatin, cyclophosphamide and rituximab as a second-line prednisone, etoposide, procarbazine, cyclophosphamide ± rituximab as a second-line Discussion comment to consider the inclusion of venetoclax as a second-line treatment option for patients with The panel discussion and consensus was that fludarabine, mitoxantrone and rituximab should be removed as a second-line treatment option for MCL due to limited clinical use and activity. Based on the panel discussion regarding the limited data and activity for pentostatin, cyclophosphamide and rituximab for the second-line treatment of FL, the panel consensus vote resulted in the category changing from a category 2A to a category 3 recommendation. Based on the panel discussion regarding the limited data and activity for prednisone, etoposide, procarbazine, cyclophosphamide ± rituximab for the second-line treatment of FL, the panel consensus vote resulted in the category changing from a category 2A to a category 3 recommendation. Based on the noted reference and discussion, the panel consensus was to include venetoclax as a second-line treatment option for patients with This was added as a category 2A recommendation. Gerecitano JF et al. A Phase 1 study of venetoclax (ABT-199 / GDC-0199) monotherapy in patients with relapsed/refractory Non- Hodgkin Lymphoma. Blood 2015;126:Abstract

5 Diffuse Large B-cell Lymphoma (BCEL) BCEL-C Institutional review comment to include gemcitabine, vinorelbine, rituximab as a second-line and subsequent therapy option for patients with DLBCL who are not candidates for highdose therapy. Based on the panel discussion, the consensus was to include gemcitabine, vinorelbine ± rituximab as a second-line and subsequent therapy option for patients with DLBCL who are not candidates for high-dose therapy. This was added with a category 3 designation. Papageorgiou ES, Tsirigotis P, Dimopoulos M, et al. Combination chemotherapy with gemcitabine and vinorelbine in the treatment of relapsed or refractory diffuse large B-cell lymphoma: a phase-ii trial by the Hellenic Cooperative Oncology Group. Eur J Hematol 2005;75: Xiros N, Economopoulos T, Valsami S, et al. Rituximab in combination with vinorelbine/gemcitabine chemotherapy in patients with primary refractory or early relapsed T cell rich B cell lymphoma. A pilot study. Leuk Res 2003;27: Müller-Beissenhirtz H, Kasper C, Nückel H, Dührsen U. Gemcitabine, vinorelbine and prednisone for refractory or relapsed aggressive lymphoma, results of a phase II single center study. Ann Hematol 2005;84: YES NO ABSTAIN ABSENT Supportive Care NHODG-B External request Submission request from Sanofi to: Under the First-line and at retreatment for 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. Based on the of current data, the panel consensus was that the dose of rasburicase as listed in the guidelines is safe and effective. Therefore, the panel voted that the information regarding rasburicase dose should remain the same. YES NO ABSTAIN ABSENT

6 Add additional bullet: Currently the available data evaluating the use of fixed dose rasburicase are limited to use in the inpatient setting only along with careful and frequent monitoring. For outpatient use, where monitoring is limited or insufficient, the labeled weight-based dose of 0.2 mg/kg of rasburicase may be more appropriate, as well as the use of multiple rasburicase doses.