Genentech Submits Supplemental New Drug Application to FDA for Venclexta Plus Gazyva for Previously Untreated Chronic Lymphocytic Leukemia with Co-Existing Medical Conditions

基因泰克(Genentech)向 FDA 提交了补充新药申请,用于治疗有共同医疗条件的慢性淋巴细胞白血病( Venclexta Plus Gazyva )

2019-03-08 20:25:03 BioSpace

本文共8483个字,阅读需22分钟

Application is being reviewed under FDA’s Real-Time Oncology Review pilot program Combination was granted Breakthrough Therapy Designation, the fifth for Venclexta SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. The FDA is reviewing the application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. “More than 20,000 people will be diagnosed with untreated chronic lymphocytic leukemia in the United States this year, and many are ineligible for intensive chemotherapy-based options,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are encouraged that this chemotherapy-free, fixed-duration combination is being reviewed under the FDA’s Real-Time Oncology Review pilot program, and we are working closely with the agency to bring this new option to people with previously untreated chronic lymphocytic leukemia as quickly as possible.” Breakthrough Therapy Designation was granted based on results of the randomized Phase III CLL14 study, evaluating the fixed-duration combination of Venclexta plus Gazyva, compared to Gazyva plus chlorambucil, in people with previously untreated CLL and co-existing medical conditions. The study met its primary endpoint and showed a statistically significant reduction in the risk of disease worsening or death (progression-free survival [PFS] as assessed by investigator) compared to standard-of-care Gazyva plus chlorambucil. Safety for the Venclexta plus Gazyva combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Data from the CLL14 study will be presented at an upcoming medical meeting. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, M.D., University of Cologne. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. About the CLL14 Study CLL14 (NCT02242942) is a randomized Phase III study evaluating the combination of fixed-duration Venclexta plus Gazyva compared to Gazyva plus chlorambucil in patients with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. 432 patients with previously untreated CLL were randomly assigned to receive either a 12-month duration of Venclexta alongside six-month duration of Gazyva (Arm A) or six-month duration of Gazyva plus chlorambucil followed by an additional six-month duration of chlorambucil (Arm B). The primary endpoint of the study is investigator-assessed progression-free survival (PFS). Secondary endpoints include PFS assessed by independent review committee (IRC), minimal residual disease (MRD) status, overall response (OR), complete response (with or without complete blood count recovery, CR/CRi), overall survival (OS), duration of response, event-free survival, time to next CLL treatment and safety. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, M.D., University of Cologne. About CLL Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia. In the United States, it is estimated that more than 20,000 new cases of CLL will be diagnosed in 2019. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of cancerous cells. About Venclexta Venclexta is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to restore the process of apoptosis. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood and other cancers. In the United States, Venclexta has been granted five Breakthrough Therapy Designations by the U.S. Food and Drug Administration (FDA): in combination with Gazyva for people with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions; in combination with Rituxan for people with relapsed or refractory CLL; as a monotherapy for people with relapsed or refractory CLL with 17p deletion; in combination with hypomethylating agents (azacitidine or decitabine) for people with untreated acute myeloid leukemia (AML) ineligible for intensive chemotherapy; and in combination with low-dose cytarabine for people with untreated AML ineligible for intensive chemotherapy. About Gazyva Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, Gazyva is part of a collaboration between Genentech and Biogen. Combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers. Venclexta Indications Venclexta is a prescription medicine used: To treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least 1 prior treatment. In combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who: ‒ Are 75 years of age or older, or ‒ Have other medical conditions that prevent the use of standard chemotherapy. It is not known if Venclexta is safe and effective in children. Important Safety Information Venclexta can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. The patient’s doctor will do tests to check their risk of getting TLS before they start taking Venclexta. The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS. The patient may also need to receive intravenous (IV) fluids through their vein. The patient’s doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta. It is important for patients to keep appointments for blood tests. Patients should tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Patients should drink plenty of water during treatment with Venclexta to help reduce the risk of getting TLS. Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before the first dose, on the day of the first dose of Venclexta, and each time a dose is increased. The patient’s doctor may delay, decrease the dose, or stop treatment with Venclexta if the patient has side effects. Certain medicines must not be taken when the patient first starts taking Venclexta and while the dose is being slowly increased because of the risk of increased tumor lysis syndrome. Patients must tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venclexta and other medicines may affect each other, causing serious side effects. Patients must not start new medicines during treatment with Venclexta without first talking with their doctor. Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they: Have kidney problems. Have problems with body salts or electrolytes, such as potassium, phosphorus, or calcium. Have a history of high uric acid levels in the blood or gout. Are scheduled to receive a vaccine. The patient should not receive a “live vaccine” before, during, or after treatment with Venclexta, until the patient’s doctor tells them it is okay. If the patient is not sure about the type of immunization or vaccine, the patient should ask their doctor. These vaccines may not be safe or may not work as well during treatment with Venclexta. Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If the patient is able to become pregnant, the patient’s doctor should do a pregnancy test before the patient starts treatment with Venclexta, and the patient should use effective birth control during treatment and for at least 30 days after the last dose of Venclexta. If the patient becomes pregnant or thinks they are pregnant, the patient should tell their doctor right away. Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into the patient’s breast milk. Patients should not breastfeed during treatment with Venclexta. What to avoid while taking Venclexta: Patients should not drink grapefruit juice, eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient’s blood. Venclexta can cause serious side effects, including: Low white blood cell counts (neutropenia). Low white blood cell counts are common with Venclexta, but can also be severe. The patient’s doctor will do blood tests to check their blood counts during treatment with Venclexta. Patients should tell their doctor right away if they have a fever or any signs of an infection during treatment with Venclexta. The most common side effects of Venclexta when used in combination with rituximab in people with CLL include low white blood cell counts; diarrhea; upper respiratory tract infection; cough; tiredness; and nausea. The most common side effects of Venclexta when used alone in people with CLL/SLL include low white blood cell counts; diarrhea; nausea; upper respiratory tract infection; low red blood cell counts; tiredness; low platelet counts; muscle and joint pain; swelling of arms, legs, hands, and feet; and cough. The most common side effects of Venclexta in combination with azacitidine, or decitabine, or low-dose cytarabine in people with AML include low white blood cell counts; nausea; diarrhea; low platelet counts; constipation; fever with low white blood cell counts; low red blood cell counts; infection in blood; rash; dizziness; low blood pressure; fever; swelling of arms, legs, hands, and feet; vomiting; tiredness; shortness of breath; bleeding; infection in lung; stomach (abdominal) pain; pain in muscles or back; cough; and sore throat. Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility. These are not all the possible side effects of Venclexta. Patients should tell their doctor about any side effect that bothers them or that does not go away. Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555. Please visit http://www.Venclexta.com for the Venclexta full Prescribing Information, including Patient Information, for additional Important Safety Information. Gazyva Indications Gazyva® (obinutuzumab) is a prescription medicine used: With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment. With the chemotherapy drug, bendamustine, followed by Gazyva alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment. With chemotherapy, followed by Gazyva alone in those who responded, to treat stage II bulky, III, or IV FL in adults who have not had previous FL treatment. Important Safety Information The most important safety information patients should know about Gazyva Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that can become serious or life threatening, including: Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If the patient has a history of hepatitis B infection, Gazyva could cause it to return. Patients should not receive Gazyva if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen them for hepatitis B before, and monitor the patient for hepatitis during and after, their treatment with Gazyva. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. The patient’s weakened immune system could put them at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems Who should not receive Gazyva: Patients should NOT receive Gazyva if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to Gazyva. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in Gazyva in the past. Additional possible serious side effects of Gazyva: Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that may become severe or life threatening, including: Infusion Reactions: These side effects may occur during or within 24 hours of any Gazyva infusion. Some infusion reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion reactions. If the patient has a reaction, the infusion is either slowed or stopped until their symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion reaction is life threatening, the infusion of Gazyva will be permanently stopped. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each Gazyva treatment. Symptoms of infusion reactions may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort Hypersensitivity Reactions Including Serum Sickness: Some patients receiving Gazyva may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, the patient’s doctor will stop the infusion and permanently discontinue Gazyva Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving Gazyva. Gazyva works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart, and may lead to kidney failure requiring the need for dialysis treatment. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness Infections: While the patient is taking Gazyva, they may develop infections. Some of these infections may be fatal and severe, so the patient should be sure to talk to their doctor if they think they have an infection. Patients administered Gazyva in combination with chemotherapy, followed by Gazyva alone are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with Gazyva. Patients taking Gazyva plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking Gazyva plus CHOP or CVP Low White Blood Cell Count: When the patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking Gazyva, their doctor will do blood work to check their white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with Gazyva. Some cases of neutropenia can last for more than one month. If the patient’s white blood cell count is low, their doctor may prescribe medication to help prevent infections Low Platelet Count: Platelets help stop bleeding or blood loss. Gazyva may reduce the number of platelets the patient has in their blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While the patient is taking Gazyva, their doctor will do blood work to check their platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with Gazyva. Fatal bleeding events have occurred in patients treated with Gazyva. If the patient’s platelet count gets too low, their treatment may be delayed or reduced The most common side effects of Gazyva in CLL were infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea. The safety of Gazyva was evaluated based on 392 patients with relapsed or refractory NHL, including FL (81 percent), small lymphocytic lymphoma (SLL) and marginal zone lymphoma (MZL) (a disease for which Gazyva is not indicated), who did not respond to or progressed within 6 months of treatment with rituximab product or a rituximab product-containing regimen. In patients with follicular lymphoma, the profile of side effects that were seen were consistent with the overall population who had NHL. The most common side effects of Gazyva were infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, low red blood cell counts, general weakness, and urinary tract infection. A randomized, open-label multicenter trial (GALLIUM) evaluated the safety of Gazyva as compared to rituximab product in 1,385 patients with previously untreated follicular lymphoma (86%) or marginal zone lymphoma (14%).The most common side effects of Gazyva were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation, and diarrhea. Before receiving Gazyva, patients should talk to their doctor about: Immunizations: Before receiving Gazyva therapy, the patient should tell their healthcare provider if they have recently received or are scheduled to receive a vaccine. Patients who are treated with Gazyva should not receive live vaccines Pregnancy: The patient should tell their doctor if they are pregnant, think that they might be pregnant, plan to become pregnant, or are breastfeeding. Gazyva may harm their unborn baby. The patient should speak to their doctor about using Gazyva while they are pregnant. The patient should talk to their doctor or their child’s doctor about the safety and timing of live virus vaccinations to their infant if they received Gazyva during pregnancy. It is not known if Gazyva may pass into the patient’s breast milk. The patient should speak to their doctor about using Gazyva if they are breastfeeding Patients should tell their doctor about any side effects. These are not all of the possible side effects of Gazyva. For more information, patients should ask their doctor or pharmacist. Gazyva is available by prescription only. Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555. Please visit http://www.Gazyva.com for the Gazyva full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information. About the German CLL Study Group (GCLLSG) Founded in 1996 and headed by Michael Hallek, M.D., the GCLLSG has been running various Phase III, Phase II and Phase I trials in chronic lymphocytic leukemia (CLL) with the goal to provide optimal treatment to patients suffering from this disease. Among those were landmark trials like the CLL8 and the CLL11 trials which led to the current standard of care in CLL. For many years, GCLLSG has been aiming to improve not just the treatment of younger and physically fit patients, but also that of elderly and less fit patients. These patients are generally underrepresented in clinical trials although they constitute the majority of CLL patients treated by doctors in daily practice. The GCLLSG is an independent non-profit research organization supported by the German Cancer Aid (Deutsche Krebshilfe). http://www.dcllsg.de. About Genentech in Hematology For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20190307005375/en/ Media Contact: Priscilla White (650) 467-6800 Advocacy Contact: Eydith Comenencia Ortiz (650) 745-5210 Investor Contacts: Loren Kalm (650) 225-3217 Karl Mahler +41 61 687 85 03 Source: Genentech View this news release online at: http://www.businesswire.com/news/home/20190307005375/en
FDA 的实时肿瘤检查试验计划正在审查申请 联合治疗获得突破性进展,第五名为 Venclexta 加州圣弗朗西斯科.---(商业前景)——基因泰克(Genentech),罗氏(Roche)集团成员( SIX : RO , ROG ; OTCQX : RHHBY )今天宣布向美国食品药品监督管理局(Food and Drug Administration)( FDA )提交一份补充新药申请,申请 Venclexta ®( venetplax ),与 Gazyva ®( obnutuzumab )联合应用于以前未经治疗的慢性淋巴细胞白血病( CLL )和共同存在的医疗状况。美国食品和药物管理局正在审查实时肿瘤审查试点项目下的申请,目的是探索一个更有效的审查过程,以确保患者尽早获得安全和有效的治疗。 “今年,美国将有2万多人被诊断为未经治疗的慢性淋巴细胞白血病,许多人没有资格接受密集的化疗方案,”全球产品开发总监、医学医学博士(M.D.)桑德拉·霍宁( Sandra Horning )说。“我们感到鼓舞的是,这种无化疗、固定期限的联合方案正在 FDA 的实时肿瘤检查试点项目下进行审查,我们正与 FDA 密切合作,尽快将这一新的选择带给以前未经治疗的慢性淋巴细胞白血病患者。” 基于随机 III 期 CLL14研究的结果,授予了突破性治疗指定,评价了与 Gazyva +氯氨苄青霉素相比, Venclexta + Gazyva 的固定持续时间组合,其治疗对象为先前未治疗的 CLL 患者和共同存在的医疗状况。该研究符合其主要终点,并显示与标准护理的 Gazyva 加氯霉素相比,疾病恶化或死亡的风险(研究者评估的无进展生存[ PFS ]显著降低)。Venclexta + Gazyva 联合用药的安全性与已知的单个药物的安全性概况一致,未发现新的安全性信号。CLL14研究的数据将在即将召开的医学会议上公布。CLL14研究是与德国 CLL 研究组合作进行的,该研究组由科隆大学医学博士(M.D.)博士 Michael Hallek 领导。 Venclexta 由罗氏(Roche)集团成员艾伯维(AbbVie)和基因泰克(Genentech)开发。由美国公司联合商业化,由艾伯维(AbbVie)公司在美国境外商业化。 关于 CLL14研究 CLL14( NCT02242942)是一项随机的 III 期研究,评估固定时间的 Venclexta 加 Gazyva 与 Gazyva 加氯霉素在以前未经治疗的慢性淋巴细胞白血病( CLL )和共存的医疗状况的患者中的联合作用。432例先前未治疗的 CLL 患者随机分为两组,一组接受12个月的 Venclexta 持续时间,另一组接受6个月的 Gazyva 持续时间( Arm A ),另一组接受6个月的 Gazyva 持续时间( Arm B )。研究的主要终点是研究者评估的无进展生存( PFS )。次要终点包括由独立审查委员会( IRC )评估的 PFS 、最低残留疾病( MRD )状态、整体反应( OR )、完全反应(有或无完全血计数恢复、 CR / CRi )、整体生存( OS )、响应时间、无事件生存、下次 CLL 治疗的时间和安全性。CLL14研究是与德国 CLL 研究组合作进行的,该研究组由科隆大学医学博士(M.D.)博士 Michael Hallek 领导。 关于 CLL 慢性淋巴细胞白血病( CLL )是成人白血病中最常见的类型。在美国,预计2019年将诊断出20,000多例新的 CLL 病例。虽然 CLL 的症状可能在最初治疗后一段时间内消失,但这种疾病被认为是不可治愈的,许多人将需要额外的治疗由于癌细胞的返回。 关于 Venclexta Venclexta 是一种一流的靶向药物,旨在选择性地结合和抑制 B 细胞淋巴瘤-2( BCL-2)蛋白。在某些血癌和其他肿瘤中, BCL-2可以建立并防止癌细胞死亡或自我毁灭,这一过程称为细胞凋亡。Venclexta 阻断 BCL-2蛋白,恢复细胞凋亡过程。 Venclexta 由罗氏(Roche)集团成员艾伯维(AbbVie)和基因泰克(Genentech)开发。由美国公司联合商业化,由艾伯维(AbbVie)公司在美国境外商业化。两家公司共同致力于与 Venclexta 的研究, Venclexta 目前正在几种类型的血液和其他癌症的临床试验中进行研究。 在美国,Venclexta 已获得美国食品药品监督管理局(Food and Drug Administration)( FDA )的五项突破性治疗设计:与 Gazyva 联合应用于以前未经治疗的慢性淋巴细胞性白血病( CLL )患者和共同存在的医疗状况;与 Rituxan 联合应用于复发或难治性 CLL 患者;作为复发或难治性 CLL 患者的单一治疗方案,同时删除17p ;与未治疗的急性髓细胞性白血病( AML )患者的低甲基化试剂(阿扎替丁或替卡宾)联合应用于不能进行强化治疗的 AML ;与低剂量联合应用于重症化疗。 关于 Gazyva Gazyva 是一种设计成的单克隆抗体,设计用于连接 CD20,一种只在某些类型的 B 细胞上发现的蛋白质。它被认为是通过直接攻击目标细胞和身体的免疫系统一起工作。Gazyva 是罗氏的全资独立研究单位罗氏(Roche) Glycart AG 发现的。在美国, Gazyva 是基因泰克(Genentech)和百健(Biogen)公司合作的一部分。 研究 Gazyva 与其他批准或研究的药物,包括癌症免疫疗法和小分子抑制剂的联合研究正在一系列的血癌中进行。 Venclexta 适应症 Venclexta 为处方药,用途: 治疗患有慢性淋巴细胞性白血病( CLL )或小淋巴细胞性淋巴瘤( SLL )的成年人,不论是否删除17便士,他们至少接受了1次事先治疗。 联合阿扎替丁或替布他滨或小剂量西他滨治疗新诊断的急性髓系白血病( AML )患者: 75岁或以上,或 有其他防止使用标准化疗的医疗状况。 目前尚不清楚 Venclexta 是否对儿童安全有效。 重要安全资料 Venclexta 可引起严重的副作用,包括: 肿瘤溶解综合征( TLS )。TLS 是由癌细胞快速分解引起的。TLS 可导致肾衰竭,需要透析治疗,并可能导致死亡。患者的医生将在开始服用 Venclexta 之前进行测试,以检查他们获得 TLS 的风险。患者将在开始治疗前和治疗期间接受其他药物,以帮助降低 TLS 的风险。病人可能还需要通过静脉注射静脉输液. 病人的医生将在病人第一次开始治疗时和使用 Venclexta 治疗期间进行血液检测以检查 TLS 。对病人来说,保持血液检查的预约是很重要的。患者应立即告知他们的医生,如果他们在治疗过程中有任何症状的 TLS 与 Venclexta ,包括发烧,寒战,恶心,呕吐,混乱,呼吸急促,癫痫,不规则心跳,黑暗或多云的尿液,不寻常的疲劳,或肌肉或关节疼痛。 患者在治疗过程中应该喝大量的水,以帮助减少获得 TLS 的风险。 患者应每天饮用6至8杯水(约合56盎司),从第一次剂量前2天开始,在第一次剂量的 Venclexta 当天开始,每次增加剂量。 如果病人有副作用,医生可以延迟、减少剂量或停止使用 Venclexta 的治疗。 当病人第一次开始服用 Venclexta 时,不能服用某些药物,而由于肿瘤溶解综合征增加的风险,剂量逐渐增加。 患者必须告知医生他们服用的所有药物,包括处方和非处方药、维生素和草药补充剂。Venclexta 和其他药物可能相互影响,造成严重的副作用。 患者在使用 Venclexta 治疗期间,必须首先与医生交谈,才能开始新的药物。 在服用 Venclexta 之前,患者必须告知医生他们的所有医疗状况,包括是否: 有肾脏问题. 身体盐类或电解质有问题,如钾、磷或钙。 有血液或痛风中尿酸含量高的历史。 计划接种疫苗。患者在使用 Venclexta 治疗前、治疗期间或治疗后不应接受“活疫苗”,直到患者的医生告诉他们该疫苗是可行的。如果病人不确定免疫接种或疫苗的类型,病人应该向医生咨询。这些疫苗可能是不安全的,或可能不工作,以及在治疗过程中与 Venclexta 。 怀孕或计划怀孕。Venclexta 可能伤害未出生的婴儿。如果患者能够怀孕,患者的医生应在患者开始使用 Venclexta 治疗前进行妊娠试验,患者应在治疗期间和最后一次服用 Venclexta 后至少30天内进行有效的出生控制。如果病人怀孕或认为怀孕,病人应该马上告诉医生。 母乳喂养还是计划母乳喂养?。目前还不知道 Venclexta 是否会进入患者的母乳。患者在治疗过程中不应母乳喂养。 服用 Venclexta 时要避免什么: 患者在服用 Venclexta 时不应饮用葡萄柚汁、吃葡萄柚、 Seville 橙子(常用于 marmalades )或淀粉。这些产品可能会增加病人血液中的 Venclexta 含量。 Venclexta 可引起严重的副作用,包括: 白细胞计数低(中性粒细胞减少)。低白细胞计数是常见的 Venclexta ,但也可能严重。该病人的医生将进行血液检测,以检查他们在治疗过程中的血液计数与 Venclexta 。患者应立即告知他们的医生,如果他们有发烧或任何迹象感染治疗期间与 Venclexta 。 当与利妥昔单抗联合应用于 CLL 患者时,最常见的副作用包括白细胞计数低、腹泻、上呼吸道感染、咳嗽、疲劳和恶心。 在 CLL / SLL 患者中单独使用 Venclexta 最常见的副作用包括:低白细胞计数;腹泻;恶心;上呼吸道感染;低红细胞计数;疲劳;低血小板计数;肌肉和关节疼痛;手臂、腿、手和脚肿胀;以及咳嗽。 最常见的副作用是 Venclexta 与 azacitidine 或 dectabine 联合使用,或急性髓系白血病患者低剂量的 cytarabine 包括低白细胞计数;恶心;腹泻;低血小板计数;便秘;低白细胞计数发热;低红细胞计数;低红细胞计数;血液感染;皮疹;头晕;低血压;发烧;手臂、腿、手和脚肿胀;呕吐;疲倦;呼吸急促;出血;肺部感染;胃(腹部)疼痛;肌肉或背部疼痛;咳嗽;喉咙痛。 Venclexta 可能会引起男性的生育问题。这可能会影响孩子的父亲能力。如果病人对生育有顾虑,应该和医生谈谈。 这些并不是 Venclexta 所有可能的副作用。病人应该告诉他们的医生任何困扰他们或不会消失的副作用。 向 FDA 报告副作用:1-800-FDA-1088或 http://www.fda.gov/medwatch 。报告1-888-835-2555对基因泰克(Genentech)技术的副作用。 有关更多重要安全信息,请访问 http://www.Venclexta.com 获取完整的 Venclexta 压力信息,包括患者信息。 Gasiva 标志 Gazyva ®( obnutuzumab )是处方药,用于: 与化疗药物氯霉素,治疗慢性淋巴细胞白血病( CLL )的成人谁没有以前的 CLL 治疗。 与化疗药物,苯达莫司汀,其次是 Gazyva 单独用于卵泡性淋巴瘤( FL )的成年人谁没有反应的利妥昔单抗含有的养生法,或其 FL 返回后,这样的治疗。 在没有接受过 FL 治疗的成年人中,用化疗后仅用 Gazyva 治疗 II 期肥大、 III 期或 IV 期 FL 。 重要安全资料 最重要的安全信息患者应该了解 Gazyva 病人必须马上告诉医生他们所经历的任何副作用.Gazyva 可造成可能严重或危及生命的副作用,包括: 乙型肝炎病毒( HBV ):乙型肝炎可导致肝衰竭和死亡.如果患者有乙肝感染的病史, Gazyva 可能导致其复发。如果患者有活动性乙肝肝病,不应接受 Gazyva 。患者的医生或医疗团队将需要在治疗前对其进行乙肝筛查,并在治疗过程中和治疗后对患者进行监测。有时这需要治疗乙肝。肝炎的症状包括:疲劳加重和皮肤或眼睛黄变色 进行性多焦点 Leukencepharmation ( PML ): PML 是由病毒引起的一种罕见而严重的脑部感染。PML 可能是致命的。病人的免疫系统减弱可能使他们处于危险之中。病人的医生将观察症状, PML 的症状包括:困惑、说话或行走困难、头晕或失去平衡,以及视力问题 谁不应该接受 Gazyva : 如果患者对 Gazyva 有过敏反应(如过敏反应或血清疾病),则不应接受 Gazyva 。患者必须告诉他们的医疗保健提供者,是否有过敏反应 obnutuzumab 或任何其他成分在 Gazyva 过去。 Gazyva 可能产生的其他严重副作用: 病人必须马上告诉医生他们所经历的任何副作用.Gazyva 可导致可能变得严重或危及生命的副作用,包括: 输液反应:这些副作用可能发生在或在24小时内的任何 Gazyva 输液。有些输液反应可能是严重的,包括但不限于严重过敏反应(过敏反应)、急性危及生命的呼吸问题或其他危及生命的输液反应。如果病人有反应,输液要么减缓,要么停止,直到症状得到解决。大多数患者能够完成输液并再次接受药物治疗。然而,如果输液反应危及生命,输注 Gazyva 将永久停止。患者的医疗团队将采取措施帮助减轻患者可能对输液过程产生的任何副作用。病人在接受 Gazyva 治疗前可以服用药物。输液反应症状可能包括:心跳快、疲倦、头晕、头痛、面部红肿、恶心、寒战、发热、呕吐、腹泻、皮疹、高血压、血压低、呼吸困难、胸部不适 包括血清疾病在内的过敏反应:一些接受 Gazyva 的患者可能出现严重或危及生命的过敏反应。这种反应可能是严重的,可能发生在输液期间或之后,并可能影响身体的许多领域。如果发生过敏反应,患者的医生将停止输液并永久停止 Gazyva 肿瘤溶解综合征( TLS ):肿瘤溶解综合征,包括致命病例,已报告的患者接受 Gazyva 。Gazyva 致力于快速分解癌细胞。随着癌细胞的分裂,它们的含量被释放到血液中。这些内容可能会对器官和心脏造成损害,并可能导致肾衰竭,需要透析治疗。患者的医生可能会开出药物来帮助预防 TLS 。患者的医生还将定期进行血液检测以检查 TLS 。TLS 的症状包括恶心、呕吐、腹泻和疲劳 感染:当病人服用 Gazyva 时,他们可能会发生感染。其中一些感染可能是致命的和严重的,因此病人应该确保与他们的医生,如果他们认为他们有感染。治疗期间和治疗后,接受 Gazyva 联合化疗的患者,其次是单纯 Gazyva ,有感染的高风险。有复发或慢性感染病史的患者可能面临更高的感染风险。有主动侵染的病人不应接受 Gazyva 的治疗。与服用 Gazyva + CHOP 或 CVP 的患者相比,服用 Gazyva +苯达莫司汀的患者发生致命或严重感染的风险更高 白细胞计数低:当患者有异常低的抗感染白细胞计数时,称为中性粒细胞减少。当病人服用 Gazyva 时,他们的医生会做血液检查,检查他们的白细胞数量。严重和威胁生命的中性粒细胞减少可以在治疗期间或之后发展与 Gazyva 。一些中性粒细胞减少病例可以持续一个多月。如果患者的白细胞数量较低,医生可能会开出药物来帮助预防感染 低血小板计数:血小板有助于止血或失血.Gazyva 可以减少患者血液中的血小板数量;血小板计数低被称为血小板减少症。这可能影响凝血过程。当病人服用 Gazyva 时,他们的医生会做血液检查他们的血小板计数。严重和威胁生命的血小板减少症可以在治疗期间发展与 Gazyva 。接受 Gazyva 治疗的患者发生了脂肪出血事件。如果患者的血小板计数过低,他们的治疗可能会延迟或减少 在慢性淋巴细胞白血病中, Gazyva 最常见的副作用是输液反应、白细胞计数低、血小板计数低、红细胞计数低、发热、咳嗽、恶心和腹泻。 对392例复发或难治性 NHL 患者,包括 FL (81%)、小淋巴细胞性淋巴瘤( SLL )和边缘区淋巴瘤(未指明为 Gazyva 的疾病)进行安全性评价。他们在治疗6个月内没有对利妥昔单抗产品或含有利妥昔单抗产品的养生法作出反应或取得进展。在滤泡性淋巴瘤患者中,观察到的副作用与 NHL 的总体人群一致。最常见的副作用是输液反应,低白细胞计数,恶心,疲劳,咳嗽,腹泻,便秘,发烧,低血小板计数,呕吐,上呼吸道感染,食欲下降,关节或肌肉疼痛,鼻窦炎,低红细胞计数,一般虚弱,泌尿道感染。 一项随机、开放标签的多中心试验( GALLIUM )评估了1,385例以前未治疗的滤泡性淋巴瘤(86%)或边缘区淋巴瘤(14%)患者 Gazyva 与利妥昔单抗产品的安全性。最常见的副作用是输液反应,白细胞计数低,上呼吸道感染,咳嗽,便秘,腹泻。 在接受 Gazyva 治疗前,患者应与医生沟通: 免疫接种:在接受 Gazyva 治疗之前,患者应该告诉他们的医疗保健提供者他们最近是否接受或计划接受疫苗。接受 Gazyva 治疗的患者不应接种活疫苗 怀孕:病人应该告诉医生他们是否怀孕,认为他们可能怀孕,计划怀孕,或正在母乳喂养。Gazyva 可能会伤害他们未出生的婴儿。病人在怀孕期间应该和医生谈谈使用 Gazyva 的情况。如果婴儿在怀孕期间接受了 Gazyva 的疫苗接种,患者应该与医生或其孩子的医生沟通疫苗接种的安全性和时机。目前尚不清楚 Gazyva 是否会进入患者的母乳。如果病人正在母乳喂养,应该和医生谈谈使用 Gazyva 的情况 病人应该告诉医生任何副作用. 这些并不是 Gazyva 可能产生的所有副作用。更多的信息,病人应该问他们的医生或药剂师。 Gazyva 仅按处方提供。 向 FDA 报告副作用(800) FDA-1088,或 http://www.fda.gov/medwatch 。向基因泰克(Genentech)技术公司报告副作用(888)835-2555。 有关更多重要安全信息,请访问 http://www.Gazyva.com 获取 Gazyva 的全部压力信息,包括 BOXED WARNINGS 。 关于德国 CLL 研究组( GCLLSG ) GCLLSG 成立于1996年,由医学博士(M.D.)博士 Michael Hallek 领导,在慢性淋巴细胞白血病( CLL )中开展了各种 III 期、 II 期和 I 期试验,旨在为患有这种疾病的患者提供最佳治疗。其中包括具有里程碑意义的试验,如 CLL8和 CLL11试验,导致目前的标准护理在 CLL 。多年来, GCLLSG 的目标不仅是改善年轻和身体健康的病人的治疗,而且改善老年人和不太健康的病人的治疗。这些患者在临床试验中的代表性普遍较低,尽管他们在日常实践中构成了大多数接受医生治疗的 CLL 患者。GCLLSG 是一个独立的非盈利研究组织,由德国癌症援助组织( Deutsche Krebhilf )提供支持。http://www.dcllsg.de 。 关于血液学基因泰克(Genentech)技术 20多年来,基因泰克(Genentech)技术公司一直在开发药物,目的是重新定义血液学治疗。今天,我们比以往任何时候都投入更多的精力,为血液疾病患者提供创新的治疗选择。有关详细信息,请访问 http://www.gene.com/hydrology 。 关于基因泰克(Genentech)技术 基因基因泰克(Genentech)成立于40多年前,是一家领先的生物技术公司,致力于发现、开发、生产和商业化治疗严重威胁生命的疾病患者的药物。该公司是罗氏(Roche)集团的成员之一,总部位于加利福尼亚州的旧金山。有关公司的其他信息,请访问 http://www.gene.com 。 查看 businesswire 上的源代码。com : https://www.businesswire.com/news/home/20190307005375/en/ 媒体联系人: Priscilla White (650)467-6800 宣传联络: Eydith Cominencia Ortiz (650)745-5210 投资者联系方式: Loren Kalm (650)225-3217 Karl Mahler +416678503 资料来源:基因泰克(Genentech)技术 在线查看本新闻稿,网址为: http://www.businesswire.com/news/home/20190307005375/en

以上中文文本为机器翻译,存在不同程度偏差和错误;偶尔因源网页结构局限,内容无法一次完整呈现。请理解并参考原站原文阅读。

阅读原文