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On October 12, AstraZeneone's application for the listing of methyl sulfonate Ocitini tablets in China is to be included in the priority review for complementary treatment after tumor excision in adult patients with non-small cell lung cancer (NSCLC) sensitive mutations of the skin growth factor complex (EGFR).
Oxitinib is an irreversible third-generation EGFR tyrosine kinase inhibitor that inhibits both EGFR-sensitive mutations and EGFR-T790M drug-resistant mutations, which are more capable of penetrating the blood-brain barrier than first- and second-generation EGFR-TKIs and have good efficacy in patients with combined central nervous system metastasis.
Osetini was first approved in China in March 2017 for disease progression during or after treatment with the topical growth factor inhibitor (EGFR) tyrosine kinase inhibitor (TKI), and tested positive for EGFR T790M mutation in adult patients with local late stage or metastasis non-small cell lung cancer (NSCLC).
September 3, 2019, methyl sulfonate oxytinib tablets were approved for first-line treatment of adult patients with EGFR mutation-positive local late stage or metastasis non-small cell lung cancer (NSCLC).
In October 2018, Ociltini successfully entered the list of Medicare Class B drugs through health care negotiations, and as a second-line treatment for advanced non-small cell lung cancer, the standard payment for health insurance was 510 yuan (80mg/tablet), 300 yuan (40mg/tablet), a decrease of 70%, and sales in China increased significantly.
Oshitini has been approved as a first-line standard treatment in the United States, the European Union and Japan, with strong sales, with sales of $1.86 billion in 2018, accounting for about 31% of AstraZeneone's oncology revenue, rising to $3.189 billion in 2019, and China's market performance gradually climbing.
source: The phase III ADAURA study data presented at the Pharmaceutical Rubik's Cube Pharma GoESMO2020 Conference show that Oghidini can lead to clinically significant central nervous system (CNS) disease-free survival (DFS) improvements in the complementary treatment of patients with EGFRm NSCLC who received a complete tumor excision (IB, II and IIIA).
patients in the esotinib-assisted treatment group had fewer relapses or deaths (11% vs. 46%) than in the placebo group.
38 percent of patients in the Oghitini group had metastasis recurrence, up from 61 percent in the placebo group.
significantly reduces the risk of recurrence or death of the central nervous system by 82% (HR 0.18).
two groups did not achieve a disease-free lifetime (CNS DFS) of the central nervous system.
In addition, an after-the-fact analysis suggested that among patients who had not previously experienced relapse in other areas, patients treated with oxytinib were less than 1 percent more likely to experience a recurrence of brain disease at 18 months, compared with 9 percent in the placebo group.
study focused on disease-free survival in terminal-II and IIIA patients, Oghithini-assisted therapy reduced the risk of recurrence or death by 83% (HR 0.17).
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