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Home , Capmatinib, Entrectinib, Larotrectinib, Oligoastrocytoma, Selumetinib, Trastuzumab emtansine

NCCN Guidelines for Central v.1.2021 – Annual 10/23/2020

Guideline Page Institution Vote Panel Discussion/References

and Request YES NO ABSTAIN ABSENT GLIO-1, GLIO-5 Based on a review of the data and discussion, the 0 24 0 5 External request: panel consensus did not support the addition of these specific recommendations into the Guidelines as they Submission/NX Development Corp (06/02/20): agree that this is already covered in the Guideline. For the Anaplastic , Anaplastic Oligoastrocytoma, Anaplastic , Anaplastic and (GLIO-1) workflow, under surgery, we recommend inclusion of Aminolevulinic acid hydrochloride (ALA, Brand Name Gleolan™) as an adjunct for the visualization of malignant tissue and to improve the completeness of resection during fluorescence guided surgery.

For the Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma, , Anaplastic Gliomas and Glioblastoma (GLIO-5) workflow, under recurrence resection, we recommend inclusion of Aminolevulinic acid hydrochloride (ALA, Brand Name Gleolan™) as an adjunct for the visualization of malignant tissue and to improve the completeness of resection during fluorescence guided glioma surgery. GLIO-2 The panel consensus supported the removal of 24 0 0 5 Internal request: “Standard RT + neoadjuvant or adjuvant PCV” for adjuvant treatment of anaplastic astrocytoma Consider removal of “Standard RT ÷ neoadjuvant or adjuvant PCV” for adjuvant treatment of anaplastic astrocytoma BRAIN-D (1 of 15, 2 of 15, 3 of 15) The panel consensus supported the inclusion of 24 0 0 5 Internal request: and for tumors with NTRK gene fusion for recurrent or progressive disease Consider including larotrectinib and entrectinib for under useful in certain circumstances for low-grade NTRK gene fusion tumors. glioma, anaplastic gliomas, and glioblastoma.

NCCN Guidelines for Cancers Cancer v.1.2021 – Annual 10/23/2020

BRAIN-D (1 of 15) The panel consensus supported the inclusion of 24 0 0 5 Internal request: BRAF/MEK inhibitors / and / for tumors with BRAF Consider BRAF/MEK inhibitors dabrafenib/trametinib V600E activation for recurrent or and vemurafenib/cobimetinib for tumors with BRAF progressive disease under useful in certain V600E activation mutation. circumstances for low-grade glioma, anaplastic gliomas, and glioblastoma. BRAIN-D (1 of 15) Based on a review of the data and discussion, the 24 0 0 5 External request: panel consensus supported the inclusion of (for with BRAF AstraZeneca/Medical Affairs (May 4, 2020). Add fusion or BRAF v600E activating mutation) as an selumetinib as a treatment option for recurrent or option for recurrent or progressive disease. This is a progressive disease in patients with low-grade category 2A useful in certain circumstances glioma/pilocytic and infiltrative supratentorial recommendation. astrocytoma/oligodendroglioma. See Submission for references

External request:

AstraZeneca/Medical Affairs (May 4, 2020). The Panel consensus was that this request is outside 0 24 0 5 Based on the recent approval of KOSELUGO™ of the scope of the Guidelines recommendations. (selumetinib) by the FDA, we respectfully request for consideration the addition of a new section on plexiform to be included within the NCCN Guidelines for Central Nervous System Cancers. In addition, we request selumetinib be included as a treatment option for pediatric patients with type 1 (NF1) and plexiform neurofibromas (PN). BRAIN-D (8 of 15) Based on a review of the data and discussion, the 24 0 0 5 Internal request: panel consensus supported the inclusion of “ado- emtansine (TDM1)” for brain Consider “ado-trastuzumab” for brain metastases from metastases from HER2 positive . This HER2 positive breast cancer. is a category 2A recommendation.

Reference: Montemurro F, Delaloge S, Barrios CH, et al. (t-dm1) in patients with her2-positive and brain metastases: Exploratory final analysis of cohort 1 from kamilla, a single-arm phase iiib . Ann Oncol 2020;31:1350-1358. NCCN Guidelines for Central Nervous System Cancers Cancer v.1.2021 – Annual 10/23/2020

BRAIN-D (8 of 15) Based on a review of the data and discussion, the 24 0 0 5 Internal request: panel consensus supported moving to HER2 non-specific breast cancer, for brain Consider moving capecitabine (category 2B) from metastases. This is a category 2A recommendation. HER2 positive breast cancer to HER2 non-specific breast cancer. BRAIN-D (8 of 15) Based on a review of the data and discussion, the 0 24 0 5 External request: panel consensus was to make no change regarding the requested inclusion of + for Submission/Bristol Myers Squibb (06/23/20): Consider patients with brain metastases and wait the inclusion of nivolumab + ipilimumab for patients for publication of the data. with melanoma brain metastases. See Submission for references

BRAIN-D (8 of 15) Based on a review of the data and discussion, the 24 0 0 5 External request: panel consensus supported the removal of “(EGFR T790M positive)” after “”. Submission/AstraZeneca (04/14/20): We respectfully request that the specification “(EGFR T790M positive)” See Submission for references be removed after “osimertinib” from BRAIN-D Page 8 of 15 in the NCCN Guidelines of Central Nervous System Cancers Version 1.2020. BRAIN-D (8 of 15) Based on a review of the data and discussion, the 24 0 0 5 Internal request: panel consensus supported the inclusion of as a treatment option for NSCLC with There are now approved MET/ROS and RET inhibitors. MET exon 14 skipping mutation and brain MET is the more meaningful since its 3-4% of NSCLC metastases. This is a category 2A recommendation. and may be a resistance mechanism. Do we want to add this? It is FDA approved. Reference: Wolf J, Seto T, Han JY, et al. Capmatinib in met exon 14-mutated or met-amplified non-small- External request: cell lung cancer. N Engl J Med 2020;383:944-957.

Novartis Pharmaceuticals Corporation (December 11, 2020) consider inclusion of capmatinib as a treatment option for advanced NSCLC with MET exon 14 skipping mutation and brain metastases.