Posted from: Wednesday, August 02, 2017 - 01:16 PM - Present

Nerlynx Approved as Adjuvant for HER2+ Breast Cancer

July 17, 2017 – The U.S. FDA has approved Nerlynx™ (neratinib), manufactured by Puma Biotechnology, Inc. Nerlynx is a tyrosine kinase inhibitor indicated for extended adjuvant treatment of adults who have early stage HER2-overexpressed/amplified breast cancer. Intended to prevent cancer recurrence, it will be used following adjuvant treatment with Herceptin® (trastuzumab).

The National Cancer Institute estimates that approximately 250,000 American women will be diagnosed with breast cancer in 2017. Approximately 15% of breast cancers are HER2 positive, an aggressive form of the disease that recurs for up to 25% of patients even after treatment with surgery and Herceptin.

Nerlynx is the first drug to receive FDA approval for long-term adjuvant treatment of HER2-positive breast cancer. The recommended dosage is six 40mg tablets taken once daily for one year. Patients should take Imodium® (loperamide) for at least the first eight weeks of Nerlynx treatment, as approximately half of participants who received Nerlynx in clinical trials developed serious diarrhea.

Puma plans to launch Nerlynx in September. Perjeta® (pertuzumab), which is manufactured by Genentech and has been on the market since 2012 as a treatment for HER2-positive breast cancer in combination with Herceptin, may compete with Nerlynx as a treatment to prevent recurrences.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Wednesday, September 20, 2017 - 01:13 AM.