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    Home > Active Ingredient News > Drugs Articles > 6 new drugs approved for listing in May

    6 new drugs approved for listing in May

    • Last Update: 2020-06-17
    • Source: Internet
    • Author: User
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    According to the latest results of the FDA's official website, the FDA's approval of new drugs in May is still strong, in May, six new drugs were approved, this is the most approval of new drugs so far in 2020Less than half a year into 2020, the FDA has approved 22 new drugs, and the number of new drugs expected to be approved for the full year is expected to exceed 2019Figure 1: The number of new drugs approved by the FDA since 2000six new drugs approved by the FDA in May, all of which are new molecular entities and also cover a number of disease areasTabrecta is the first FDA-approved targeted therapy for METex14 mutant metastatic NSCLCRetevmo, which treats three types of tumors, is the first FDA-approved cancer drug to treat cancers that carry reT gene changesQinlock is the first FDA-approved target drug for four-wire treatment of gastrointestinal methomaArtesunate is currently the only drug approved in the United States to treat severe malariaThere are also two radiodiagnostic agents, Cerianna and Tauvid, which provide important assistance in the clinical screening of breast cancer and the assessment of Alzheimer's disease, respectivelyTable 1: Details of FDA approval of new drugsMET Target Heavy Drug:Tabrectib (capmatinib)May 6, 2020, Novartis announced that the FDA has accelerated approval of Tabrecta (Capmatinib) for the treatment of patients with locally advanced or metmetex isotopic 14 jump (METEX 14) mutations in non-small cell lung cancer (NSCLC)Tabrecta is the first FDA-approved, the world's second targeted therapy for METex14 mutant metastatic NSCLCPreviously, Tabrecta was granted the FDA's Breakthrough Therapy and Orphan Drug Qualification, and its new drug application was also eligible for priority reviewLung cancer is the world's leading type of lung cancer, with non-small cell lung cancer the most common type of lung cancer, accounting for about 85-90% of all lung cancer casesMET is one of the driving genes for cancer, accounting for about 3-4% of all cases with MET mutations in non-small cell lung cancer Excellent clinical trial data provide a solid foundation for Tabrecta's approval data show that Tabrecta has significant therapeutic effects, regardless of whether the patient has previously been treated Tabrecta had an overall remission rate of 68% among patients at first, and Tabrecta had a total remission rate of 41% among treated patients The median duration of remission in both groups was 11.14 months and 9.72 months, respectively Tabrecta's active ingredient, capmatinib, is an oral MET inhibitor that helps stop tumor cells from growing by blocking the expression of mutations in the MET gene At present, MET target is considered to be a rising star in the field of cancer, a number of domestic pharmaceutical companies have been targeted for THE layout and development of MET-targeted drugs Table 2: Progress in domestic MET-targeted drug development (incomplete statistics) multi-tumor new drug: Retevmo (selpercatinib) May 8, 2020, FDA officially approved Retevmo (Retevmo) developed by Lilly subsidiary Loxo Oncology selpercatinib, for the treatment of patients with 3 types of cancer, including: treatment of metastatic RET fusion-positive non-small cell lung (NSCLC), advanced or metastatic RET mutation thyroid myelin cancer (MTC) and advanced or metastatic RET fusion-positive thyroid cancer Retevmo is the first FDA-approved cancer drug to treat a gene change that carries RET Previously, Retevmo has been granted FDA status for orphan drugs, breakthrough drugs, priority review, and more The approval is based primarily on single-arm multicenter I/II clinical trial data called LIBRETTO-001 The clinical trial included both patients with primary treatment and patients with various advanced physical tumors treated, and evaluated the efficacy of Retevmo in the treatment of patients with RET gene changes through two endpoint indicators, objective remission rate (ORR) and median duration (DOR) Table 3: Retevmo Clinical Trial Data (Note: NR is not reached) Retevmo on the treatment of non-small cell lung cancer, 105 patients treated with ORR is 64%, 81% of patients dOR is 6 months, 39 patients with primary treatment, ORR is 84%; Of the 88 patients treated at first,olysage patients had 73% ORR and 61% of patients had DOR for 6 months, 19 patients with thyroid cancer who had received another system therapy had ORR of 79%, 87% of the patients with dOR were 6 months, and in 8 patients with untreated thyroid cancer, ORR was 100% and 75% of patients with dor was 6 months giST's first four-wire treatment: On May 15 , 2020, Qinlock (Ripretinib), a pharmaceutical partner, received FDA approval for the listing of the quadripyoma (GIST) for advanced gastrointestinal interstitial oma (GIST) The drug is the first FDA-approved target drug for four-line treatment of gastrointestinal methoma Qinlock is suitable for adult patients who have previously received treatment with three or more kinase inhibitors, including imatinib, sunitinib, regorafenib Qinlock's approval was three months ahead of the target action date and was granted FDA-awarded breakthrough drugs, orphan drugs, fast-track, priority reviews, and more Currently, the drug is also declared a clinical trial in China Gastrointestinal interstitial tumor is a rare interlopathy tumor, the main cause of 80%-90% is THE KIT gene mutation, 5%-10% is the PDGFRA gene mutation, resulting in tyrosine kinase activation, cell growth out of control and cancer Prior to this, the FDA approved a total of four targeted drugs for patients with gastrointestinal interstitial omas, but some patients did not respond after the above treatment, the tumor continued to develop, in which case Qinlock can give patients new hope The validity and safety of Qinlock were validated in Phase III clinical trial data called INVICTUS The data showed that the median progression-free survival (PFS) in patients treated with Qinlock reached 6.3 months, 5.3 months more than the control group Qinlock reduced the risk of disease progression or death by 85%, and the median total survival of patients in the Qinlock group was 15.1 months, significantly better than that of the control group (6.6 months), and reduced the risk of death by 64% Table 4: FDA approves gastrointestinal methography radioactive diagnostic agent: Cerianna (fluoroestriol F18) May 20, 2020, FDA approves Zionexa's radioactive diagnostic agent Cerianna (fluorostiol F18) as an auxiliary to biopsy and isactive elifio imaging (PET) to detect estrogen-like transsexual (PET) The approval of the PET contrast agent Cerianna provides another option for clinical screening for breast cancer fluorostiol F18 chemical lysis CERIANNA is a sterile, clarified, colorless intravenous solution, the active ingredient of fluorostediol F18 (fluoroestrdiol F18) is a synthetic estrogen analogue The approval was supported by a clinical trial that included data from 90 women whose hetles confirmed to be breast cancer The results were scored, and 36 of the 47 biopsy-positive patients tested positive for imaging, 38 of the 38 biopsy-negative patients were imaging negative, and 10 of the 11 imaging-negative patients were positive artemisinin antimalarial: On May 26, 2020, the FDA announced the approval of Amivas' Artesunat e intravenous injection for the treatment of adults and children with severe malaria Artemisinin is currently the only approved drug in the United States to treat severe malaria Previously, artemisinin intravenous agents also obtained the FDA-granted orphan drug qualification, the new drug application also received priority review qualification Artesunate chemically structured malaria is a parasitic disease transmitted by mosquito bites, which is as prevalent and dangerous as other major diseases such as cancer This is because once malaria becomes severe, it affects the central nervous system The WHO estimates that the number of malaria cases worldwide will exceed 220 million in 2018, resulting in about 405,000 deaths the safety and effectiveness of the intravenous treatment of severe malaria with artemisinin were evaluated in two clinical trials In a randomized controlled trial in Asia and a supportive randomized controlled trial in Africa, the number of patients treated with artemisinin in hospital was significantly lower than in the control group treated with quinine First Drug for Tau Pathology of Alzheimer's Disease: Tauvid (Flortaucipir F18) May 28, 2020, Lilly's radioactive diagnostic agent Tauvid (Flortaucipir F18) was officially approved by the FDA for use in the brain's positron emission tomography (PET) imaging to assess the density and distribution of tau neurogenic fibrosis (NFT) that accumulates in the brain Tauvid helps adult patients with cognitive impairment who need a Cognitive Impairment who need a AD assessment by judging one of the main markers of Alzheimer's disease (AD) - tau neurogenic fibrosis It is also the first fda-approved drug to help image tau pathology in the brain Alzheimer's disease is a hidden progressive degenerative disease of the nervous system that currently has no completely cured drug, and the use of diagnostic imaging can help patients and their families better plan for the future approval is based on data from two clinical studies In the first study, independent pathologists evaluated the density and distribution of NFTs in brain tissue after death of a patient's Tauvid brain scan imaging and patients The comparison between the two shows that the evaluators who interpreted the Tauvid image had a higher chance of correctly judging the presence of tau pathology in patients, and the accuracy of the assessment of patients without tau pathology was medium to high a second study that examined the consistency between the interpretation of the Tauvid evaluator and other assessment results The consistentness of interpretation is 1, and the completely consistent consistency is 0 In this study, the reading consistency for all 241 patients was 0.87 Subgroup analysis showed that the consistency was 0.82 in 82 patients with end-stage disease and 0.90 for 159 patients with cognitive impairment
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