2020 Tumor New Drug Data Card - Nairatini

In 2020, the State Drug Administration (NMPA) approved a total of 16 new cancer drugs.
Based on the Pharmaceutical Rubik's Cube NextPharma database, NextMed database, the 2020 edition of the new anti-tumor drug clinical application guidelines and public information, the pharmaceutical Rubik's Cube Med specifically launched the "Oncology New Drug Data Card" to introduce some key information of the new cancer drug listed in China for your reference.
Nerlynx is a powerful irreversible tyrosine kinase inhibitor that inhibits tumor growth and metastasis by blocking the transductivity of pan-HER families (HER-1, HER-2 and HER-4) and downstream signaling.
first FDA-approved ante-HER2 extension-assisted therapy in July 2017.
the drug was listed in China on April 28, 2020 with special approval.
Q2 listing background about 20%-25% of breast cancer overexposed HER2 protein.
HER2-positive breast cancer is generally more aggressive than other types of breast cancer and has a higher risk of recurrence, progress and death.
despite studies showing that terojumal monoantion can reduce the risk of recurrence of early HER2-positive breast cancer after surgery, 25% of patients still relapse after receiving quertojudanantotherapy.
patients with relapsed metastatic HER2-positive breast cancer are usually incurable, the metastasis site includes the lateral breast, brain, lungs, bones, etc., brain metastasis is one of the main causes of death.
January 2018, Beihai Kangcheng signed an exclusive license agreement with Puma Biotechnology for the development and commercialization of Nerlynx in Chinese mainland, Taiwan, Hong Kong and Macau.
was approved in Hong Kong in November 2019.
april 28, 2020, Nairatini was approved for listing by NMPA.
Q3 indication nairatinib was approved in China as follows: suitable for adult patients with her2-positive early breast cancer, after receiving intensive complementary treatment after receiving monoantigen-assisted treatment with curvature.
Nerlynx Worldwide in the research and development of adaptive progress against HER2 adaptive disease layout Q4 treatment costs are currently, the listing price of Neratini in China has not been officially announced.
is not yet on the national health-care list.
2019, Nerlynx had sales of $212 million.
annual sales chart Q5 evidence-based data and core clinical nairatinib approval in China is based on a randomized multi-center clinical Phase III trial ExteNET.
study included 2840 cases of HER-2-positive breast cancer patients in stage II. - III. 1 year of oral lanatinie-assisted therapy within 2 years of the end of the treatment of closto-pearl monoantigen.
median follow-up time of 5.2 years showed a 2.3% increase in iDFS (94.2% vs. 91.9%) over two years compared to the placebo group, with significant statistical differences, with more benefit from hormone-positive populations.
ExteNET study core data based on exteNET clinical study data for patients in Asia and China reported at the 2018 CSCO Conference showed similar benefits in five years of invasive disease survival (iDFS) in Asia and China subgroups compared to global data.
46% lower risk of recurrence in the Asian group and 40% less risk of recurrence in the China subgroup.
another Phase III NALA study showed that for 621 patients who had received ≥2-line HER-2-positive metastasis breast cancer, the Nelatini-Carpentamine treatment group showed a 24 percent lower risk of disease progress or death (HR-0.76, P-0.006), and PFS showed a significant improvement in OS.
the benefits of the Chinese sub-group are consistent with or even better than the overall population.
for patients with brain metastasis, the Nairatini treatment group also observed effective benefits.
NALA Study Core Data Q6 Guidelines recommend 1. Domestic and International Guide Comparison (NCCN/ESMO/CSCO) NCCN Note: For patients with a high risk of recurrence of HR-plus, HER2-plus, consider the use of extended nilatine-assisted therapy after complementary therapy with virulated monoantigen.
the benefits or toxicity associated with nairatinie prolongation therapy are not clear to patients who have received patojuquine monoanti or enmetroquine monoantigen therapy.
2. CSCO Guidelines for Breast Cancer Diagnosis and Treatment (2020 edition) Auxiliary treatment for HER-2-positive breast cancer without new complementary treatment for HER-2-positive breast cancer: armpit lymph node-positive patients, level III recommends the addition of "H post-sequential natinie";
notes, patients who have completed the querceton monomath and are at risk of recurrence may consider sequential mentini.
patients with initial anti-HER-2 complementary therapy should first consider the double-target treatment of cratural bead monoantigen and combined pato-pearl monoantigen.
Q7 reasonable drug use point 1. Patients considering the use of the drug need to be tested for HER2, HER2 positive patients can be treated with nairatinib.
2. The recommended dose of nairatini is 240 mg, once a day, taken with meals, for one year in a row.
instruct patients to take nairatinie at approximately the same time each day and to swallow nairatinini throughout (the tablets should not be chewed, crushed or split before swallowing).
if the patient misses the dose, do not supplement the missed dose, the patient should be instructed to re-take nairatini on a daily dose the next day.
3. The main adverse reaction is diarrhoea.
preventive use of anti-laxatives, dietary changes and appropriate adjustment of the dose of nairatinie can reduce the incidence of diarrhoea and the severity of diarrhoea.
to instruct patients to start taking the laxative lorpentamine preventively for 2 cycles (56 days) at the time of the first dose of nairatini.
, depending on clinical needs, diarrhea can be controlled by temporarily interrupting nairatinie or reducing its dose, with a minimum niratinie dose of 120 mg/day.
4. The initial dose of nilatiniids was reduced to 80 mg in patients with severe liver impairment.
dose adjustment is not recommended for patients with mild and moderate liver impairment.
5. Drug interactions: (1) Proton pump inhibitors (PPI): Avoid taking drugs in co-drugs with nairatinib.
(2) H2 subject antagonist: Take nairatinib at least 2 hours before the next dose of H2 subject antagonist or 10 hours after the dose of H2 subject antagonist.
(3) antaics: nyladium can only be given 3 hours after the antastic drug is given.
(4) avoid nairatinib with strong or moderate CYP3A4 inducers.