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Home , Ivosidenib

NCCN Guidelines for Acute Myeloid V.1.2020 – Meeting – May 14, 2019

Guideline Page Panel Discussion/References Institution Vote and Request YES NO ABSTAIN ABSENT EVAL-1 Internal request to add the option to Based on discussion, the panel consensus was to include one 17 0 0 10 consider administration of one dose of dose of intermediate dose cytarabine (1-2 gm) as an option for intermediate dose cytarabine (1-2 gm) for patients with highly proliferative cancers while awaiting results of patients with highly proliferative cancers molecular and cytogenetic analyses that may identify immediately while awaiting results of molecular and actionable mutations. cytogenetic analyses that may identify • This is a category 2A recommendation. immediately actionable mutations. AML-1 (formerly AML-8) External request from Pfizer Inc, Pfizer Based on discussion, the panel consensus was to not make 0 19 0 8 Oncology (4/22/19) to consider updating changes to the current recommendations. AML-8, as well as relevant discussion sections, by deleting “(up to one 4.5 mg vial)” in connection with dosing for patients less than 60 years old. AML-2 (formerly AML-9) External request from Jazz Based on discussion, the panel consensus supported changing 17 0 0 10 Pharmaceuticals (3/14/19) to consider the language to “preferred only if given in induction” regarding changing the phrase "if given in induction" dual-drug liposomal encapsulation of daunorubicin and cytarabine to "preferred if given in induction" for re-induction, post-remission, and consolidation. regarding dual-drug liposomal encapsulation of daunorubicin and cytarabine for re-induction, post-remission, and consolidation. (Also on AML-4 [formerly AML-11], AML-7 [formerly AML- 14], and AML-8 [formerly AML-15]) AML-4 (formerly AML-11) Internal request to consider adding Based on discussion, the panel consensus supported the addition 14 3 0 10 HiDAC + gemtuzumab ozogamicin as a of HiDAC + gemtuzumab ozogamicin as a treatment option for treatment option for AML patients <60 AML patients <60 years of age with core binding factor years of age with core binding factor cytogenetic translocations without KIT mutations. cytogenetic translocations without KIT • This is a category 2A recommendation. mutations.

External request from Jazz Based on discussion, the panel consensus supported the change. 17 0 0 10 Pharmaceuticals (3/7/19) to revise the post-remission dosing of the dual-drug liposomal encapsulation of daunorubicin NCCN Guidelines for V.1.2020 – Meeting – May 14, 2019

and cytarabine for the treatment of AML (see submission for full details). (Also on AML-8 [formerly AML-15]) AML-5 (formerly AML-12) Internal request to consider removing Based on discussion, the panel consensus was that azacitidine 11 8 0 8 single-agent azacitidine as a treatment has limited clinical use for the treatment of AML patients ≥60 option for AML patients ≥60 years of age years of age with unfavorable cytogenetic results and the with unfavorable cytogenetic results who category was changed from a category 2A to a category 2B are candidates for intensive remission recommendation. induction therapy.

External request from Agios Based on a review of data and discussion, the panel consensus 0 17 0 10 Pharmaceuticals, Inc. (4/2/19) to consider did not support the inclusion of ivosidenib due to insufficient the addition of ivosidenib in combination available data. with induction for patients that have been newly diagnosed with IDH1-mutation positive AML and are candidates for intensive chemotherapy. AML-6 (formerly AML-13) Internal requests: • Consider removing the “preferred” Based on discussion, the panel consensus supported the change. 17 0 0 10 category distinction for hypomethylating agents (azacitidine and decitabine) when used as treatment options for patients ≥60 years of age who have been diagnosed with AML and are not candidates for intensive remission induction therapy (or decline).

• Reassess low-dose cytarabine as a Based on discussion, the panel consensus was that low-dose 5 13 0 9 treatment option for patients ≥60 years cytarabine has limited clinical use for the treatment of AML in of age who have been diagnosed with patients ≥60 years of age without actionable mutations, and the AML (without actionable mutations) category was changed from a category 2A to a category 3 and are not candidates for intensive recommendation. remission induction therapy (or decline).

• Reassess gemtuzumab ozogamicin as Based on discussion, the panel consensus was that gemtuzumab 9 9 0 9 a treatment option for patients ≥60 ozogamicin has limited clinical use for the treatment of AML in years of age who have been patients ≥60 years of age without actionable mutations, and the diagnosed with AML (without category was changed from a category 2A to a category 2B actionable mutations) and are not recommendation. NCCN Guidelines for Acute Myeloid Leukemia V.1.2020 – Meeting – May 14, 2019

candidates for intensive remission induction therapy (or decline). Also for patients ≥60 years of age who have had a response to previous lower intensity therapy (AML-9 [formerly AML-16]).

External requests: • Request from Agios Pharmaceuticals, Based on a review of data and discussion, the panel consensus 0 18 0 9 Inc. (4/2/19) to consider the addition of did not support the addition of ivosidenib in combination with SC ivosidenib in combination with azacitidine due to insufficient available data. subcutaneous (SC) azacitidine for the treatment of patients who have been diagnosed with IDH1-mutation positive AML and are ineligible for intensive chemotherapy (or decline).

• Request from AbbVie and Genentech Based on a review of data and discussion, the panel consensus 18 0 0 9 (3/21/19) to consider including supported the inclusion of in combination with venetoclax in combination with azacitidine, decitabine or low-dose cytarabine as treatment azacitidine, decitabine or low-dose options for patients who are ineligible for intensive remission cytarabine as a “preferred” treatment induction therapy (or decline) and who have AML without recommendation for patients who are actionable mutations, or who have IDH1, IDH2 or FLT3 ineligible for intensive remission mutations. These regimens were listed as “preferred” options for induction therapy (or decline) and who AML without actionable mutations. have IDH1, IDH2 or FLT3 mutations. • These are category 2A recommendations. • See submission for references. AML-9 (formerly AML-16)

External request from AbbVie and Based on discussion, the panel consensus was to not make 0 18 0 9 Genentech (3/21/19) to consider modifying changes to the current recommendations. response assessment footnote specific to venetoclax treatment to: “Perform bone marrow to assess response starting at the end of cycle 1 as median time to first response with venetoclax was approximately 1-2 months (range: < 1 month to 14.9 months).” NCCN Guidelines for Acute Myeloid Leukemia V.1.2020 – Meeting – May 14, 2019

AML-H Internal request to consider adding Based on discussion, the panel consensus supported the addition 18 0 0 9 venetoclax + HMA/LDAC as a less of venetoclax + HMA/LDAC as a less aggressive therapy option aggressive therapy option for AML patients for AML patients with relapsed/refractory disease. with relapsed/refractory disease. • This is a category 2A recommendation.

External requests: • Requests from Astellas Pharma Inc. Based on discussion and the noted references, the panel 18 0 0 9 (1/18/19 and 6/5/19) to consider consensus was that is supported by high-level evidence gilteritinib as a category 1 and the category was changed from a category 2A to a category recommendation for the treatment of 1 recommendation. FLT3 mutation-positive patients with • See submission for references. relapsed or refractory AML.

• Request from Daiichi-Sankyo (4/19/19) to consider the addition of The Panel consensus was to defer the submission until FDA 0 18 0 9 for the treatment of adult patients with approval. relapsed/refractory FLT3-ITD AML.

• Request from Jazz Pharmaceuticals (4/26/19) to consider Based on a review of data and discussion, the panel consensus 3 14 0 10 adding the phrase “consider dual-drug did not support the inclusion of dual-drug liposomal encapsulation liposomal encapsulation of of daunorubicin and cytarabine as a therapy option for daunorubicin and cytarabine for select relapsed/refractory disease due to insufficient available data. patients" under aggressive therapy for appropriate patients BPDCN-3 External requests from Stemline Based on a review of data and discussion, the panel consensus 18 0 0 9 Therapeutics (12/13/18 and 4/24/19) to supported the inclusion of tagraxofusp-erzs for the treatment of consider inclusion of tagraxofusp-erzs for first-line and relapsed/refractory BPDCN. the treatment of patients with first-line and • These are category 2A recommendations. relapsed/refractory BPDCN. • See submissions for references.