• NERLYNX® (neratinib) is approved by the Food and Drug Administration for The Philippines
  • Leading regional breast cancer oncologists say the availability of NERLYNX is a “big step forward” for women in The Philippines who have been diagnosed with HER2+ breast cancer at an early stage
  • Five-year follow-up data show that NERLYNX reduces the risk of recurrence of invasive disease by 42% in women with early-stage HER2+/HR+ breast cancer who start treatment within 12 months of end of treatment with trastuzumab 1

SINGAPOREJuly 8, 2022 /PRNewswire/ — A NEW drug that has been shown to significantly reduce the risk of cancer recurrence or death in an aggressive form of breast cancer is now approved by the Philippine Food and Drug Administration.

The drug NERLYNX (neratinib) is an oral drug taken daily for 12 months by women who have been diagnosed with HER2-positive (HER2+) breast cancer at an early stage and who have previously received treatment with trastuzumab.

It has been approved by the Food and Drug Administration for The Philippines “for extended adjuvant treatment of adult patients with HER2-overexpressed/enhanced early-stage breast cancer to undergo trastuzumab-based adjuvant therapy.”

The greatest benefit is seen in women who are hormone receptor positive (HR+) and start treatment with NERLYNX within 12 months of completing trastuzumab treatment. Their risk of recurrence over five years is reduced by 42% after 12 months of treatment with NERLYNX.1

President of The Philippines’ Cardinal Santos Medical Center, Dr Ma. Luisa Abesamis-Tiambengsaid the approval of NERLYNX was “a big step forward” for women in The Philippines who have been diagnosed with early breast cancer that is both HER2+ and HR+.

Dr Tiambeng commented: “We know that one in four women with this type of breast cancer are still at risk of recurrence, despite treatment with chemotherapy and trastuzumab therapy after their initial breast surgery. this important Food and Drug Administration approval of The PhilippinesNERLYNX presents a new opportunity for women in this region to benefit from prolonged adjuvant therapy to further reduce their risk of relapse.”

NERLYNX is made available by an independent pharmaceutical company, Specialized Therapeutics (ST).

Chairman and Chief Executive Officer ST Carlo Montagner declared that NERLYNX was the first therapy in the company’s therapeutic portfolio to gain approval in The Philippines.

“There are regulatory nuances in every jurisdiction in which we operate, and this latest approval is a testament to the skill of our regulatory team as they navigate complex jurisdictions,” he said.

“From the patients’ point of view, this is the first time that the women of The Philippines are offered the opportunity to extended– an adjuvant treatment which will reduce the risk of recurrence of the disease.

“We are thrilled to be at the forefront of this new treatment paradigm and look forward to evolving outcomes for these women, their families and friends.”



NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor that blocks signal transduction by epidermal growth factor receptors, HER1, HER2 and HER4.2

NERLYNX is the first HER2-targeting drug approved by the U.S. Food and Drug Administration (FDA) for the extended adjuvant treatment of adult patients with HER2+ early-stage breast cancer who have previously been treated with trastuzumab after surgery (i.e. trastuzumab therapy).seven NERLYNX is also the first anti-HER2 treatment to be approved by the European Commission (EC) for extended adjuvant treatment of adult patients with HR+/HER2+ early-stage breast cancer who have completed adjuvant HER2 therapy. trastuzumab less than a year ago.8

Extended adjuvant therapy is the next stage of treatment following adjuvant therapy (treatment after surgery) to further reduce the risk of breast cancer recurring.

NERLYNX is an oral tablet and works by binding to several receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.2

About HER2+ breast cancer

Up to 20% of patients with breast cancer tumors overexpress the HER2 protein (HER2+ disease) and in the ExteNET study, 57% of patients had HR+ tumours. HER2+ breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of recurrence of HER2+ breast cancer early after surgery, up to 25% of patients treated with adjuvant therapy with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.3

About the ExteNET Study1,3,4

The ExteNET trial was a phase III, double-blind, placebo-controlled study comparing neratinib to placebo after adjuvant treatment with trastuzumab and chemotherapy in patients with HER2+ early-stage breast cancer.

The ExteNET study randomized 2,840 patients in 41 countries with early-stage HER2+ breast cancer who had undergone surgery and adjuvant therapy with trastuzumab. After completion of adjuvant trastuzumab therapy, patients were randomized to receive neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years after randomization.

The primary endpoint of the trial was invasive disease-free survival (iDFS) with a 34% reduction in the risk of recurrence and an absolute benefit of 2.3% compared to placebo at 2 years (HR = 0, 66; 95% CI: 0.49, 0.90 p=0.008). The trial demonstrated that after a median follow-up of 5.2 years, treatment with neratinib resulted in a 27% reduction in the risk of invasive disease recurrence or death compared to placebo (hazard ratio = 0.73, p = 0.008). The 5-year iDFS rate for the neratinib arm was 90.2% and the 5-year iDFS rate for the placebo arm was 87.7%.1 In the overall survival (OS) analysis after a median follow-up of 8.0 years (range: 0-9.8 years), 53 (7.9%) of 670 patients in the neratinib group and 68 (10.2 %) of the 664 patients in the placebo group of the HR+/≤ 1 year population had died. The OS hazard ratio was 0.79 (95% CI, 0.55-1.13) and the estimated 8-year OS rates were 91.5% (95% CI, 88.9 % to 93.5%) in the neratinib group and 89.4% (95% CI, 86.6%-91.6%) in the placebo group of the HR+/≤ 1 year population, i.e. an absolute difference between groups 2.1%.4

Additional five-year subgroup analysis demonstrated a 42% risk reduction in women who were HR+ and started treatment with neratinib within 12 months of completing treatment with trastuzumab-based therapy .5

The most common adverse reactions (≥ 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, increased AST or ALT, nail disorders , dry skin, abdominal distension, epistaxis, weight loss and urinary tract infection.2

A Phase II CONTROL study investigated various prophylactic antidiarrheal regimens for the first 1-2 cycles of neratinib treatment. The data suggest that prophylactic management reduces the incidence, severity, and duration of neratinib-associated diarrhea compared to events seen in ExteNET.6

About Specialized Therapy

Based at SingaporeSpecialized Therapeutics (ST) is a global biopharmaceutical company delivering novel specialty therapies and technologies to patients through South East AsiaAs good as inside Australia and New Zealand. ST and its regional subsidiaries work with leading global pharmaceutical and diagnostic companies to bring innovative and breakthrough healthcare solutions to patients affected by various diseases. Its mission is to provide therapies where there is an unmet need. The company’s extensive therapeutic portfolio currently includes new agents in oncology, hematology, neurology, ophthalmology and supportive care.

Additional information can be found at


1. Martin M, et. Al. Lancet Oncol. 2017;18(12):1688-1700.

2. Nerlynx product information in the Philippines.

3. Chan A, et. Al. Lancet Oncol. 2016;17(3):367-377.

4. Chan A, et al. Clin Breast Cancer 2021; 21(1):80-91.

5. Gnant M, et al. SABCS 2018 P2-13-01.6.

6. Barcenas CH et al., 2020; 31(9):1223-1230

7. Nerlynx US Prescribing Information

8. Nerlynx EU Summary of Product Characteristics

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