NCCN Guidelines for B-Cell Lymphomas V Update Meeting 08/14/18

Transcription

1 DIAG-1 Submission request from Adaptive Biotechnologies to add NGS as an additional option to PCR for assessing IGH and TCR gene rearrangements under Essential Diagnosis: (immunohistochemistry, flow cytometry, NGS or PCR for IGHV and TCR gene rearrangements ). NHODG-B 3 of 3 Consider adding febuxostat as a treatment option for hyperuricemia. Based on a review of data and discussion, the panel did not use the language proposed in the submission. However, the panel supported adding the following language: If a high suspicion of a clonal process remains and other techniques have not resulted in a clear identification of a clonal process, then next generation sequencing can be used. Based the discussion, the panel consensus was to add febuxostat as a first-line and retreatment option for hyperuricemia NHODG-B 3 of 3 Submission request from Jazz Pharmaceuticals that the NCCN Panel to consider adding the following new section on CSLL-C 4 of 4: "Hepatic veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS) Hepatic VOD is a rare but lifethreatening complication following hematopoietic stem cell transplant (HSCT) or chemotherapy without HSCT: The panel consensus was to not include this request since it is outside of the scope of the Guidelines recommendations

2 o o o Defibrotide for treatment of patients who develop hepatic VOD. Treatment with defibrotide has been shown to result in a 38% to 49% survival rate at 100 days after HSCT in patients with VOD with multi-organ dysfunction (MOD), compared with a historical control rate of 21% to 31%. In 488 patients with VOD without MOD post HSCT, from a large expanded access protocol, defibrotide therapy resulted in 69% survival at 100 days. In patients who developed VOD postchemotherapy without HSCT, defibrotide therapy resulted in 66% survival with MOD and 81% survival without MOD at 70 days post initiation of defibrotide.

3 Follicular Lymphoma (FOLL) FOLL-B Panel discussion to reassess the recommendation of lenalidomide + rituximab as a first-line therapy option for FL based on the results of RELAVANCE trial. Submission from Celgene respectfully request updating the recommendation for the lenalidomide + rituximab combination treatment regimen to a Category 2A, preferred first-line therapy for follicular lymphoma (Grade 1-2). Submission from Celgene, as noted in the June 3, 2018 submission, we respectfully request updating the recommendation for the lenalidomide + rituximab combination treatment regimen to a Category 2A, preferred first-line therapy for follicular lymphoma (Grade 1-2). Based on the data and panel discussion, the consensus was to update the recommendation for lenalidomide + rituximab to the preferred first-line therapy option and to change this from a category 2B to a category 2A recommendation. The panel consensus was that the data do not support a category 1 recommendation

4 FOLL-B Submission from Bayer Healthcare Pharmaceuticals respectfully request the NCCN to consider to modify the indication for copanlisib from stating: copanlisib (refractory to at least two prior therapies} to state: copanlisib (relapse after two prior systemic therapies). Panel discussion to reassess the qualifier, "refractory to both alkylator and rituximab for idelalisib as second-line and subsequent therapy option for FL. Based on the panel discussion, the consensus was to revise the qualifier for copanlisib as second-line and subsequent therapy option for FL as relapsed/refractory after 2 prior therapies. Based on the panel discussion, the consensus was to revise the qualifier for idelalisib as second-line and subsequent therapy option for FL as relapsed/refractory after 2 prior therapies Marginal Zone Lymphoma (MZL) MZL-A Submission from Bayer Healthcare Pharmaceuticals to review data for compendium listing of copanlisib as therapy for adult patients with relapsed or refractory Marginal Zone lymphoma (MZL) based on the results of the phase II open label (CHRONOS-1) trial. Based on the noted reference and discussion, the panel consensus was to include copanlisib (relapsed/refractory after 2 prior therapies) as a second-line and subsequent therapy option. This was added as a category 2A recommendation

5 Mantle Cell Lymphoma (MANT) MANT-A Institutional review comment to reassess the inclusion of R- DHAC (rituximab, dexamethasone, cytarabine, carboplatin) as an induction regimen under the aggressive treatment options for patients with MCL. MANT-A Comment to consider the inclusion of venetoclax + ibrutinib as a second-line treatment option for patients with MCL. MANT-A Submission request from Pharmacyclics and Janssen Biotech, Inc to consider the available data on ibrutinib in patients with MCL. Based on the data and panel discussion, the consensus was to include R-DHAC (rituximab, dexamethasone, cytarabine, carboplatin) as an induction regimen under the aggressive treatment options for patients with MCL. Based on the data and panel discussion, the consensus was to include venetoclax + ibrutinib as a second-line treatment option for patients with MCL. This was added as a category 2B recommendations. After considering the data referenced in submission, the panel consensus was to not make a change to the guidelines Diffuse Large B-Cell Lymphoma (BCEL)

6 BCEL Panel discussion to reassess the inclusion of brentuximab vedotin for CD30+ disease as a second-line and subsequent therapy. Based on the data and panel discussion, the consensus was for brentuximab vedotin for CD30+ disease to remain an option for second-line and subsequent therapy. This was changed from a category 2B to a category 2A recommendation