A message about COVID-19 Learn more

Now approved in metastatic HER2+ breast cancer

NERLYNX® (neratinib) tablets is now the first and only HER2-directed small molecule approved in both early and metastatic breast cancer. Based on positive results in the NALA trial,* the FDA has approved the use of NERLYNX, in combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2+ breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.


Study Design

NALA was a pivotal phase 3, global, multicenter, randomized, open-label study of NERLYNX + capecitabine vs lapatinib + capecitabine1,2

NALA was a pivotal phase 3, global, multicenter, randomized, open-label study of NERLYNX + capecitabine vs lapatinib + capecitabine

NERATINIB (NERLYNX) INCLUDED AS PART OF A CATEGORY 2A TREATMENT OPTION FOR HER2+ METASTATIC DISEASE BY NCCN GUIDELINES® FOR BREAST CANCER3

Study population: 621 adults with HER2+ mBC (HER2 status was confirmed centrally); all patients had ≥2 prior lines of HER2-directed therapy for mBC; asymptomatic and stable brain metastases permitted

Co-primary endpoints: PFS (confirmed centrally) and OS

Secondary endpoints: PFS (confirmed locally), ORR, DoR, time to intervention for symptomatic CNS metastases, safety, health outcomes

Stratification: Number of prior HER2 therapies for mBC; hormone receptor status; disease location; geographic location

Nerlynx patients in NALA were heavily pretreated2

  • All patients received prior trastuzumab. In addition, 51.8% of patients received prior trastuzumab emtansine, 40.4% of patients received prior pertuzumab, and 32.9% of patients received trastuzumab emtansine, pertuzumab, and trastuzumab for mBC prior to NERLYNX2

CNS: central nervous system; DoR: duration of response; HER: human epidermal growth factor receptor; mBC: metastatic breast cancer; ORR: objective response rate; OS: overall survival; PFS: progression-free survival.

*Loperamide was administered for the first 21 days of treatment with NERLYNX + capecitabine: 4 mg with the first dose of NERLYNX, followed by 2 mg every 4 hours for the first 3 days, followed by 2 mg every 6 to 8 hours through day 21.2

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.

Study Data

IN METASTATIC HER2+ BREAST CANCER PATIENTS AFTER ≥2 PRIOR LINES OF HER2-DIRECTED THERAPY FOR mBC

The most common adverse reactions when used with capecitabine (reported in ≥ 5% of patients) were: diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

Protect against progression1

  • 29% PFS rate at 12 months with NERLYNX + capecitabine vs 15% with lapatinib + capecitabine

  • NERLYNX + capecitabine significantly improved median PFS vs lapatinib + capecitabine: 5.6 months with NERLYNX + capecitabine vs 5.5 months with lapatinib + capecitabine (HR=0.76; 95% CI: 0.63, 0.93; P=0.0059)

  • Median overall survival trended in favor of NERLYNX + capecitabine in patients with HER2+ mBC: 21 months with NERLYNX + capecitabine vs 18.7 months with lapatinib + capecitabine (HR=0.88; 95% CI: 0.72, 1.07; P=0.2086)

  • CI: confidence interval; HR: hazard ratio

Prevent tumor growth1

  • 2.9 month increase in median duration of response with NERLYNX + capecitabine vs lapatinib + capecitabine

  • Median duration of response of 8.5 months with NERLYNX + capecitabine vs 5.6 months with lapatinib + capecitabine

Dosing

Dosing with NERLYNX + capecitabine in mBC

NERLYNX + CAPECITABINE IS ADMINISTERED IN A 21-DAY DOSING CYCLE1,†

Dosing with NERLYNX + capecitabine in mBC

Administer loperamide starting with the first dose of NERLYNX: 4 mg TID on days 1-14; 4 mg BID on days 15-56; then 4 mg PRN (not to exceed 16 mg per day).

Recommended dose of NERLYNX is 240 mg once daily

Recommended dose of capecitabine is 1500 mg/m2 (750 mg/m2 BID)

  • Instruct patients to take capecitabine with water within 30 minutes after a meal on days 1 to 14 of each 21-day cycle2

References:
  • 1.  NERLYNX [package insert]. Los Angeles, CA; Puma Biotechnology, Inc.
  • 2.  Puma Biotechnology, Inc. Data on file. 02/20.
  • 3.  Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed February 5, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org.

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.