NERLYNX

How NERLYNX (Neratinib) Helps Patients with Breast Cancer

Receiving a diagnosis of HER2-positive breast cancer can be daunting. Thanks to advances in targeted therapies, many women now survive and thrive after treatment. But one challenge remains: the risk of recurrence. This is where NERLYNX (neratinib) steps in—a medicine designed to help keep cancer from coming back.

What is NERLYNX?

NERLYNX is an oral targeted therapy used after completion of standard HER2-targeted treatment such as trastuzumab (Herceptin). It belongs to a class of drugs known as tyrosine kinase inhibitors (TKIs), which work by blocking the HER2 protein from sending growth signals to cancer cells.

  • Approved by: U.S. FDA (2017) and EMA (2018)
  • Indication: Extended adjuvant treatment in early-stage HER2-positive breast cancer
  • Form: Oral tablets (taken once daily)

Clinical Facts: How NERLYNX Works

NERLYNX was studied in a major clinical trial called the ExteNET trial, which involved 2,840 patients who had completed trastuzumab therapy.

Key Findings:

  • 34% reduction in the risk of invasive disease recurrence (especially in the first 2 years after trastuzumab)
  • The benefit was most significant in patients who were hormone receptor-positive
  • Over 5 years of follow-up, patients on NERLYNX had fewer recurrences, especially in the brain and distant organs

📌Source: ExteNET Phase III Trial, published in The Lancet Oncology, 2016

Clinical Facts: How NERLYNX Works

NERLYNX was studied in a major clinical trial called the ExteNET trial, which involved 2,840 patients who had completed trastuzumab therapy.

Key Findings:

  • 34% reduction in the risk of invasive disease recurrence (especially in the first 2 years after trastuzumab)
  • The benefit was most significant in patients who were hormone receptor-positive
  • Over 5 years of follow-up, patients on NERLYNX had fewer recurrences, especially in the brain and distant organs

📌Source: ExteNET Phase III Trial, published in The Lancet Oncology, 2016


Real-World Example:

Meena, 45, from Bangalore, completed 1 year of trastuzumab after surgery and chemotherapy. Her oncologist was concerned about the risk of recurrence due to her HER2+ and hormone receptor-positive profile. She was prescribed NERLYNX for 12 months. Despite initial side effects like mild diarrhea, managed with medication, she completed the course and remains disease-free at 3 years of follow-up.


Who Should Consider NERLYNX?

NERLYNX is typically suitable for:

  • Patients with early-stage HER2-positive breast cancer
  • Those who completed trastuzumab within the past 12 months
  • Especially hormone receptor-positive women
  • Those at high risk of recurrence, such as node-positive or larger tumors

Side Effects – And How to Manage Them

The most common side effect of NERLYNX is diarrhea, which usually occurs in the first few weeks. However, studies have shown this can be effectively managed with early anti-diarrheal treatment.

Common Side Effects:

  • Diarrhea (93% cases, but only ~40% severe)
  • Nausea, abdominal pain, fatigue, vomiting

👩‍⚕️Tip: Doctors often prescribe loperamide (Imodium) to start on Day 1 to control this early.


Is NERLYNX Available in India?

NERLYNX is not commercially available in India yet. However, it can be accessed legally and safely under the Named Patient Program (NPP).

MitoGENE Helps By:

  • Assisting your doctor with the required documents
  • Coordinating with regulatory bodies
  • Importing the medicine under proper authorization
  • Ensuring secure, cold-chain delivery to your location

A Story of Access:

Anita, 39, from Mumbai, faced challenges accessing NERLYNX after her doctor recommended it post-trastuzumab. Through MitoGENE’s NPP services, she was able to import the medicine from Europe with proper permissions. With our team guiding her through every step, her treatment started on time and was delivered under cold-chain conditions.


Final Thoughts

NERLYNX offers an extra layer of protection against breast cancer recurrence—especially for women most at risk. While it’s not yet sold in Indian pharmacies, MitoGENE makes it possible to access this therapy legally and safely.

If you or someone you love may benefit from NERLYNX, speak to your oncologist—and connect with MitoGENE for personalized support and guidance.


Disclaimer: This information is based on open sources and does not replace medical advice. Always consult your treating doctor before starting any treatment. MitoGENE facilitates access under Indian regulations but does not prescribe or promote medicines.