Indications: Nerlynx® (neratinib) tablets, for oral use, is a kinase inhibitor indicated:
“When I found out I was cancer free, for a moment, I felt some kind of relief . . . but the reality is that I can never really stop worrying.”
Real patient with HER2+ HR+ breast cancer who had a pCR. NERLYNX was not commercially available at the time of treatment. Photograph taken April 2013.
26%
At 10 years in the ITT population (node-positive or high-risk node-negative disease)
in the ITT population (node-positive or high-risk node-negative disease)
Trastuzumab in combination with AC➞T (n=2028) vs 38% with AC➞T (n=2018)
12%
At 3 years in the ITT population
in the ITT population
Trastuzumab emtansine (n=743) vs 23% with trastuzumab (n=743)
17%
At 3 years in patients with residual node-positive disease
in patients with residual node-positive disease
Trastuzumab emtansine (n=343) vs 32% with trastuzumab (n=346)
15%
At 5 years in patients with a pCR
in patients with a pCR
Neoadjuvant treatment with various combinations of trastuzumab, docetaxel, and pertuzumab (n=94)
Trial and population | Analysis timepoint | N | Neoadjuvant population | CNS recurrence, % | |
---|---|---|---|---|---|
Comparator | Treatment | ||||
Adjuvant trastuzumab meta-analysis | - | 9020 | N/A | 1.94 | 2.56 |
ALTTO* | 3 years | 5190 | ~8% | 2 | 2 |
APHINITY† node (+) or high-risk node (-) | 3 years | 4805 | 0 | 1.8 | 1.9 |
No pCR post neoadjuvant treatment | |||||
KATHERINE‡ high-risk | 3 years | 1486 | N/A | 4.3 | 5.9 |
Limitations: This report is a retrospective analysis of data from the published literature. Due to the relative low incidence of CNS disease as the site of first recurrence, the number of patients in each study was low. The analysis did not allow for a true cross-trial comparison as the patient populations differed among the trials.10
had CNS metastases
as the first site of recurrence (44/78)12
had CNS metastases
as the first site of recurrence (49/141)13
of patients with HER2+ breast cancer experiencing recurrence develop brain metastases at some point14
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 1-800-332-1088 or www.fda.gov/medwatch.
Drug Interactions:
Use In Specific Populations:
Please see Full Prescribing Information.
Indications: Nerlynx® (neratinib) tablets, for oral use, is a kinase inhibitor indicated: