Nerlynx's treatment for early breast cancer has been approved in Singapore

Puma Biotechnology is a biopharmaceutical company focused on developing and commercializing innovative products to enhance cancer care. Recently, the company announced that its authorized partner, Specialized Therapeutics Asia (STA), has launched Nerlynx (neratinib, naratinib), a breast cancer-targeted treatment in Singapore, which is suitable for intensive complementary therapy in adult patients with early breast cancer who have expressed/amplified HER2 over-expression/amplification. Nerlynx was approved by the Singapore Health Sciences Authority (HSA) in December 2019, six months ahead of schedule. Prior to approval, a number of patients in Singapore had been treated with Nerlynx through a designated patient-approved drug program.Nerlynx is an oral drug used in women with HER2 plus early stage breast cancer who have underwent surgery, chemotherapy, and virulated monoantial therapy. Data from ExteNET, a Phase III clinical trial, confirmed that Nerlynx significantly reduced the risk of recurrence in patients with HER2 plus early breast cancer, benefiting most from women who were positive for hormone-positive (HR-plus) and who started Nerlynx therapy within 12 months of completing terratin monoantigen-assisted therapy, for which the risk of recurrence was reduced by 42 percent over five years.At present, in the clinical, the effective treatment of tumor has been mainly surgical removal, in addition to surgery treatment is called auxiliary treatment, the purpose is to eliminate the remaining small metastasis lesions, reduce the chance of tumor recurrence and metastasis, improve the cure rate. Intensive complementary therapy is the next step after complementary therapy to further reduce the risk of breast cancer recurrence. Nerlynx's launch will provide a new and important treatment option for female breast cancer patients, further reducing the risk of recurrence of HER2-positive breast cancer. In terms of medication, the recommended dose of Nerlynx is 240 mg (6 tablets 40 mg), oral once daily, with food, continuous treatment for one year. It is important to note that preventive treatment against diarrhoea should be initiated when Nerlynx is first given and continued for the first 2 treatment cycles (56 days), after which preventive treatment against diarrhoea may continue to be given if necessary to prevent drug-based diarrhoea.It is worth mentioning that in early November 2019, Puma's Nerlynx's authorized partner in Greater China, North Sea Kangcheng Pharmaceutical Co., Ltd. (North Sea Kangcheng, CANbridge), announced that Nerlynx was approved for listing in Hong Kong. This is the first time Nerlynx has been approved in Greater China and the first cancer-targeted treatment drug in Beihai Kangcheng. Beihai Kangcheng signed Nerlynx's exclusive license agreement with Puma in January 2018 in Greater China, and in September of the same year submitted an application for the listing of a new drug to the State Drug Administration of China (NMPA) for formal acceptance of an intensive assisted treatment for HER2-positive early breast cancer patients after completing crater mono-anti-assistance therapy.Dr Yap Yoon-Sim, an oncologist at singapore's National Cancer Centre and an investigator on the ExteNET trial, said: "The introduction of Nerlynx offers breast cancer patients a new option to further reduce the risk of recurrence.Some patients with HER2-plus breast cancer are at high risk of recurrence even if they receive standard chemotherapy and viruloxatrogen-assisted treatment. Depending on the size of the tumor and the number of lymph nodes affected, this risk may be 10%-30% in the first five years. We know that even five years after diagnosis, the risk of recurrence persists, especially in patients with hormone-positive (HR-plus) breast cancer. Nerlynx can provide additional benefits in reducing the risk of recurrence, especially in patients with high-risk diseases. Essentially, this gives the patient another chance to stay disease-free. Breastthe most common cancer affecting women in Singapore, accounting for almost 30 per cent of all cancer cases, according to singapore Health Data. It is estimated that one in 15 women is diagnosed with breast cancer before the age of 75.
Breast cancer is the most common tumor in women, with about 20%-25% of breast cancer tumors overexposing her2 protein. HER2-positive breast cancer tends to be more aggressive than other types of breast cancer, increasing the risk of disease progress and death. Despite studies showing that quertoju monoantion can reduce the risk of recurrence after surgery for early HER2-positive breast cancer, about 25% of patients still relapse after receiving quertojudanantotherapy. Recurring metastatic HER2-positive breast cancer patients are usually incurable, the metastasis site includes the lateral breast, brain, lungs, bones, etc., brain metastasis is one of the main causes of death.Nerlynx is an oral, powerful, irreversible tyrosine kinase inhibitor (TKI) that inhibits tumor growth and metastasis by blocking the transductivity of pan-HER families (HER1, HER2, HER4) and downstream signaling paths. The mechanism of action of the drug is different from that of Roche Hessetin (curtojudanin) and the new breast cancer drug Perjeta (Patoju single antibody), the 2nd is monoclonal antibody drug, targeting HER2-positive cancer cell surface HER2 subject.It is worth mentioning that Nerlynx is the first enhanced complementary treatment drug approved by the United States and the European Union for HER2 plus early breast cancer, which was approved in the United States in July 2017 and September 2018, respectively, for intensive complementary therapy in HER2 plus early breast cancer patients who have completed virulated mono-anti-assistance therapy.In February 2020, the FDA approved Nerlynx's new indication: Capecitabine, a new drug
early breast cancer! Nerlynx is listed in Singapore, reducing the risk of recurrence by 42%, and is listed in Hong Kong by Beihai Kangcheng!

patients with HER2-positive metastasis breast cancer who have previously received 2 or more HER2 targeted therapies for failure (third-line disease).Results from the Phase III NALA study showed that the third-line HER2-positive metastasis breast cancer in the Nerlynx-Carpedabin combination significantly extended the progression-free life of the disease (medium PFS: 8.8 months vs 6.6 months; HR:0.76,95%CI:0.63,0.93;p=0.0059), 12-month disease progression-free survival rate increased (29% vs. 15%), 24-month progression-free survival rate increased (12% vs 3%). In addition, compared to the Tykerb-Capedabin treatment group, the total lifetime (OS) of the Nerlynx-Carpentham treatment group was extended (mid-OS: 21 months vs. 18.7 months), the objective remission rate (ORR) was increased (32.8% vs 26.7%), and the medium remission duration (DOR) was extended (8.5 months vs. 5.6 months).Puma is working with authorized partners around the world to seek approval for these second adaptations in all countries and territories that currently approve Nerlynx. (Bio Valley
)