US Oncology Research plays an important role in the clinical development for NERLYNX (neratinib) tablets
NERLYNXTM is a new treatment option for early-stage HER2+ breast cancer patients following adjuvant trastuzumab-based therapy in the extended adjuvant setting
The Woodlands, Texas (September 12, 2017) — Early-stage breast cancer patients with HER2-positive tumors now have a promising new anti-HER2 treatment option in the extended adjuvant setting, thanks in large part to the efforts and expertise of US Oncology Research and McKesson Specialty Health. US Oncology Research is the pioneering research arm of The US Oncology Network and is supported by McKesson Specialty Health. US Oncology Research played an important pivotal role supporting the drug’s manufacturer, Puma Biotechnology, Inc., through the clinical trial, ExteNET that led to approval by the U.S. Food and Drug Administration (FDA) on July 17, 2017.
FDA approval for NERLYNX was based on the Phase III ExteNET trial, a multicenter, randomized, double-blind, placebo-controlled trial of NERLYNX following adjuvant trastuzumab treatment. Women (n=2,840) with early-stage HER2-positive breast cancer and within two years of completing adjuvant trastuzumab were randomized to receive either NERLYNX (n=1,420) or placebo (n=1,420) for one year.
The results of the ExteNET trial demonstrated that after two years of follow-up, a 34% reduction in risk of recurrence was demonstrated with NERLYNX versus placebo. Invasive disease-free survival (iDFS) was 94.2% in patients treated with NERLYNX compared with 91.9% in those receiving placebo (HR 0.66; 95% CI: 0.49, 0.90, p=0.008). NERLYNX demonstrated a 27% reduction in risk of recurrence through an exploratory analysis after five years of follow up versus placebo.
The most common adverse reactions (≥5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight loss, and urinary tract infection. The most common adverse reaction leading to discontinuation was diarrhea, which was observed in 16.8% of NERLYNX-treated patients. Increases in liver transaminases led to drug discontinuation in 1.7% of NERLYNX-treated patients.
“Neratinib gives our patients with HER2-positive tumors another highly effective oral treatment that can reduce the risk of their cancer returning,” said Frankie Ann Holmes, MD, oncologist with Texas Oncology and member of The US Oncology Network Breast Cancer Research Committee.
Dr. Holmes was the principal investigator for US Oncology Research, whose leadership and expertise played a leading role in NERLYNX’s clinical trial that led to FDA approval. US Oncology Research enrolled 230 patients to the trial―the largest number of patients from any network―representing approximately 10% of the 2,840 trial participants across the globe from North and South America, Europe, Australia, New Zealand and Japan. NERLYNX marks the 69th FDA approval in which US Oncology Research has contributed – a significant milestone.
“Collaboration between US Oncology Research and organizations such as Puma Biotechnology, Inc. are extremely critical to the success of clinical trials such as this,” noted Sandy Smith, vice president, US Oncology Research. “Everyone involved in these trials understands the importance and significance of working together and the importance of always keeping the patient as the primary focus.”
Puma Biotechnology, Inc. also collaborated with several other divisions of McKesson Specialty Health, enabling widespread practice and patient access to this new drug. McKesson Specialty Health’s oncology pharmacy services company, Biologics, Inc., was selected to be in the limited distribution network for NERLYNX as a specialty pharmacy provider. Physicians may submit prescriptions to Biologics via phone (800-850-4306), fax (800-823-4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.
In-office dispensing practices who would like access to NERLYNX can place orders via McKesson Specialty Health’s Customer Center or by contacting their Customer Care team at 800-482-6700.
Puma has developed the Puma Patient Lynx support program to provide patients and healthcare providers with assistance related to questions on accessing neratinib and referrals to resources that can help with reimbursement and financial assistance. More information on the Puma Patient Lynx program can be found at WWW.NERLYNX.COM or 855-816-5421.
NERLYNX™ is a tyrosine kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
Important Safety Information
There are possible side effects of NERLYNX. Patients must contact their doctor right away if they experience any of these symptoms. NERLYNX treatment may be stopped or the dose may be lowered if the patient experiences any of these side effects.
Diarrhea is a common side effect of NERLYNX. The diarrhea may be severe, and you may get dehydrated. Your healthcare provider should prescribe the medicine loperamide for you during your first 2 cycles (56 days) of NERLYNX and then as needed. To help prevent or reduce diarrhea:
- You should start taking loperamide with your first dose of NERLYNX.
- Keep taking loperamide during the first 2 cycles (56 days) of NERLYNX treatment and then as needed. Your healthcare provider will tell you exactly how much and how often to take loperamide.
- While taking loperamide, you and your healthcare provider should try to keep the number of bowel movements that you have at 1 or 2 bowel movements each day.
- Tell your healthcare provider if you have more than 2 bowel movements in 1 day, or if you have diarrhea that does not go away.
Contact your healthcare provider right away if you have severe diarrhea or if you have diarrhea along with weakness, dizziness, or fever.
Changes in liver function tests are common with NERLYNX. The patient’s doctor will do tests before starting treatment, monthly during the first 3 months, and then every 3 months as needed during treatment with NERLYNX. NERLYNX treatment may be stopped or the dose may be lowered if your liver tests show severe problems. Symptoms of liver problems may include tiredness, nausea, vomiting, pain in the right upper stomach area (abdomen), fever, rash, itching, yellowing of your skin or whites of your eyes.
Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. NERLYNX can harm your unborn baby. Birth control should be used while a patient is receiving NERLYNX and for at least 1 month after the last dose. If patients are exposed to NERLYNX during pregnancy, they must contact their healthcare provider right away.
Common side effects in patients treated with NERLYNX
In clinical studies, the most common side effects seen in patients taking NERLYNX were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis (dry or inflamed mouth, or mouth sores), decreased appetite, muscle spasms, dyspepsia, changes in liver blood tests results, nail problems, dry skin, abdominal distention, weight loss, and urinary tract infection.
Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or http://www.FDA.gov/medwatch. Patients and caregivers may also report side effects to Puma Biotechnology at 1-844-NERLYNX (1-844-637-5969).
About US Oncology Research
Supported by McKesson Specialty Health and The US Oncology Network, US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. US Oncology Research serves 60 research sites and 165 locations managing about 350 active trials at any given time. Physicians in the research network have enrolled more than 68,000 patients in over 1,500 trials since inception in 1992 and have played a role in approximately 70 FDA-approved cancer therapies, about one-third of all cancer therapies approved by the FDA to date. For more information visit www.usoncology.com/physicians/clinical-trials.
About McKesson Specialty Health
McKesson Specialty Health, a division of McKesson Corporation, works together with stakeholders across the healthcare delivery system to preserve and strengthen specialty care, passionately driven by the benefits it provides patients and the system as a whole. Through innovative provider, practice management, manufacturer and payer solutions, McKesson Specialty Health focuses on improving the financial, operational and business health of our customers and partners so they may provide the best care to patients. At McKesson Specialty Health, we believe that we are all in this together. For more information, visit www.mckessonspecialtyhealth.com.