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In HER2+ metastatic disease:

Neratinib (NERLYNX) is included as part of 2 treatment options for recurrent HER2+ breast cancer CNS metastases in the NCCN Guidelines® for Central Nervous System Cancers28
Original guideline inclusion: March 20, 2018

Category 2A*:
Neratinib + Capecitabine28

TBCRC 022 A Phase 2 Trial of Neratinib and Capecitabine for Patients With HER2+ Breast Cancer and Brain Metastases (NCT01494662)29

TBCRC 022: Neratinib + capecitabine active against progressive brain metastases in patients with HER2+ brain metastases29

NALA A Phase 3 Trial of Neratinib + Capecitabine vs Lapatinib + Capecitabine for Patients With HER2+ Breast Cancer After ≥2 HER2-Directed Regimens in the Metastatic Setting (NCT01808573)22

NALA: Neratinib + capecitabine active against symptomatic brain metastases in patients with HER2+ breast cancer22

Category 2B*:
Neratinib + Paclitaxel28

NEfERT-T Randomized, Multicenter, International Study of HER2-Directed Therapy in First-Line mBC (NCT00915018)30

NEfERT-T: Reduced CNS progression with neratinib + paclitaxel in patients with HER2+ brain metastases30

NCCN makes no warranties of any kind whatsoever regarding its content, use, or application and disclaims any responsibility for how its content is applied or used, in any way.

CNS: central nervous system; HER: human epidermal growth factor receptor; mBC: metastatic breast cancer; NCCN: National Comprehensive Cancer Network.

*Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate. Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.28

Select IMPORTANT SAFETY INFORMATION

Diarrhea: Aggressively manage diarrhea. If diarrhea occurs despite recommended prophylaxis, treat with additional anti-diarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥2 diarrhea that occurs after maximal dose reduction.

Please see additional IMPORTANT SAFETY INFORMATION below.

IMPORTANT SAFETY INFORMATION

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions (reported in ≥5% of patients) were:

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

For Full Prescribing Information, please click here.