2020 Tumor New Drug Data Card - Vibutoxi monoantigen

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, 2020 version of the new anti-tumor drug clinical application guidelines and public information, the pharmaceutical Rubik's Cube Med specially launched "oncology new drug data card", for you to introduce some key information on the domestic market of new cancer drugs for your reference.
Virbutoxi single-anti-Q1 basic information Virbutosi (Brentuximab vedotin, BV) was developed by Takeda and Seattle Genetics, a monoclonal antibody targeting CD30, Brentuximab and micro-tube destroyer MMAE through a protease-sensitive crosslinking agent, a joint technology for Seattle Genetics' proprietary technology.
BV remains stable in the blood, but after internal swallowing into cells expressing CD30, MMAE can be released and the target cells killed.
As the world's first and currently the only antibody-coupled drug (ADC) targeted at CD30, Adcetris is the first new Hodgkin's lymphoma drug approved by the FDA since 1977, the first FDA-approved drug specifically for the treatment of mesolytic large cell lymphoma (ALCL), and the second ADC drug approved in China after Enmetrozhu monoantitones.
English-language product is called Adcetris, Chinese is also called Ansili.
Q2-listed background lymphoma is a malignant tumor originating from the lymphatic hematosis system, which is commonly known as the "lymphoma family" of more than 70 different subtypes.
, lymphoma is one of the top ten malignant tumors in China.
, about 93,000 people are diagnosed with lymphoma each year in China, and more than 50,000 die from the cancer each year, according to the National People's Government.
disease map, the traditional treatment methods for relapsed or recurring systemic mesolytic large cell lymphoma and classic Hodgkin's lymphoma are relatively limited, and the survival status of patients is not optimistic.
data show that about 40% to 64% of patients with systemic mesolytic large cell lymphoma still relapse or progress after first-line treatment, and the prognosis of chemotherapy after recurrence is poor.
Q3 adaptive Adcetris was originally approved by the FDA on August 19, 2011 and is currently approved worldwide for adaptations including Hodgkin's lymphoma, primary skin interdational large-cell lymphoma, systemic mesozoic large-cell lymphoma, sarcoma, hemangioblastular T-cell lymphoma, and extrinsic T-cell lymphoma.
Adcetris has been approved in China for the treatment of adult patients with recurring/reassociative CD30-positive classic Hodgkin's lymphoma (cHL) or systemic interdational large cell lymphoma (sALCL).
CD30 adaptive research and development layout Q4 treatment cost Adcetris specification for powder needle 50 mg/bottle.
recommended in accordance with the drug instructions, the recommended dose is 1.8 mg/kg, more than 30 minutes intravenous administration, once every 3 weeks.
patients with relapsed or incurable cHL or saLCLs with stable or improved disease should receive at least 8 cycles and up to 16 cycles (approximately 1 year).
Vibutoxi monoantigen resistance is currently in the domestic winning bid price of 22,000 yuan / 50 mg, patients every 3 weeks intravenous injection of 1.8 mg / kg, up to 16 cycles, then an ordinary adult patient (60 kg) annual use costs of more than 700,000 yuan.
2019, Adcetris has global sales of $1,121 million (Seattle Genetics is responsible for $628 million in U.S. and Canada sales, and Takeda is responsible for sales of 52.7 billion yen in Japan and elsewhere).
Japan and elsewhere sales Q5 evidence-based data and core clinical first two II. phase studies SG035-0003 and SG035-0004 confirmed the effectiveness of BV in classic Hodgkin's lymphoma (CHL) and systemic mesodynatural large cell lymphoma (sALCL).
or 75% or treatable CHL patients (102 cases) were treated with BV, while the five-year survival rate was 41%, and the ORR and 5-year survival rates were as high as 86% and 60%, respectively, for patients with relapsed or resoicable sALCL (58 cases).
AETHERA (329 cases) followed up in patients with recurring or refractic Hodgkin's lymphoma further confirmed that patients were given BV 16 course consolidation therapy after self-hematopoietic stem cell transplantation (ASCT), significantly improving the patient's median PFS (42.9 vs. 24.1 months, P.0013) compared to placebo.
in other CD30-positive lymphomas, BV also showed effective.
alCANZA III. phase study (131 cases) showed that BV treatment for CD30-positive skin T-cell lymphoma (CTCL) significantly improved patients' duration of ≥4 months or ORR (13% vs. vs. vs. 56%, P.lt;0.000 1), and extend the patient's medium PFS (3.5 vs. 16.7 months, P.lt;0.0001).
Professor Song Yuqin of Peking University Cancer Hospital said in CSCO 2019 that the Virbutoxi monoanti-Chinese study data showed that the total effective rate in cHL patients reached about 70%, and in sALCL patients this data is also about 70%, although the CR rate is slightly different from foreign data, but also similar.
it's worth emphasizing that the PFS data for long-term follow-up is also good.
security aspects are similar to those reported abroad.
addition, BV is the first fda-approved first-line therapy for classic Hodgkin's lymphoma in nearly 40 years, based on Phase III ECHELON-1 trial data, with Brentuximab vedotin and AVD performing better than ABVD.
BV is also the first FDA-approved first-line therapy for outer T-cell lymphoma (PTCL).
this approval is based on Phase III ECHELON-2 test data, brentuximab vedotin and CHP significantly better than CHOP.
Data Source: NextClinTrial Database, which retains only key clinical trials for drug registration or change of guidelines; early clinical Q6 guidelines that exclude low-quality researchers initiating research, or exploratory nature conducted by pharmaceutical companies, recommend the Expert Consensus on Clinical Application of Antibody Drug Companies to Treat Malignant Tumors (2020) Consensus Recommendation: Recommended for patients with recurring incurable CD30-positive external T-cell lymphoma, recommended for BV treatment.
SALCL Preferred BV-CHP Scheme (Cyclophosphamide-Dorobi Star-Pernisson), any other CD30-positive histological subtype may be considered for the BV-CHP scheme.
patients selected in the ECHELON2 study were selected for external T-cell lymphoma of ≥10% CD30-positive tumor cells, but the threshold for CD30-positive is still highly controversial.
elderly and lung insulated patients may consider choosing a BV-AVD treatment option and recommend preventive use of granulocyte cluster stimulation factor (G-CSF) to support treatment during chemotherapy.
For the treatment of patients with relapsed or refractic CHL, the preferred second-line rescue program after chemotherapy for high-dose chemotherapy and ASCT, tumor primary drug resistance or first-line treatment within 12 months of recurrence or recurrence with adverse factors such as external lesions, asCT treatment can be carried out after BV single-drug maintenance treatment for 1 year, ASCT failure can also choose BV treatment.
addition, second-line treatments for relapsed or refractic CHL may also be considered for BV-benzomostin or Navuliyu monoantigen.
BV-AVD or daccabazine can be used as an option for the treatment of patients with poor prognostic prognosticity or III.-IV.stage CHL in the age of 60, and BV single-drug therapy as an option for patients with relapsed recurring incurable CHL at the age of 60.
Q7 Rational Drug Use Point 1. Peripheral Neuropathy: Vibutoxi monoantitherapy can cause sensory and motor neuropathy around and has cumulative effects and may require delayed medication or termination of treatment.
2. Infusion-related reactions: 13 per cent of single-drug therapy infusion reactions and 9.8 per cent of level 3 events.
hypersensitive reaction is rare and should be terminated immediately and treated accordingly if it occurs.
3. Blood toxicity: The whole blood cell count should be monitored before each dose.
4. Tumor dissolution syndrome: Patients with rapid tumor proliferation and high tumor load are at higher risk of developing tumor dissolution syndrome and should be closely monitored and appropriate measures taken.
5. Severe skin reactions include Stevens-Johnson syndrome (SJS) and toxic dermatation laxity (TEN).
should be terminated in the event of a vebutoxythion and appropriate treatment should be provided.
6. Pulmonary toxicity: including pneumonia, interstitromopathic pulmonary disease and acute respiratory distress syndrome (ARDS), should be monitored and avoided in combination with Bolcomycin.
7. The presence of vibtoxidants interacts with drugs metabolized by the CYP3A4 pathway (CYP3A4 inhibitors/inducers): such as ketoconazole, may increase the rate of neutral granulocyte reduction;
8. Increased toxicity in patients with severe renal damage: mainly due to the amassing of its co-price-coupled micro-tube inhibitor monomer auretatin E (MMAE), severe renal damage (CrCL) <30 ml/min) patients avoid the use of vibtoxima.
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