美国食品和药物管理局（FDA）最近宣布批准免疫疗法治疗组合万博专业版。The approval came on October 2, 2020 and is the first approval of this kind in over 15 years.
The treatment combines Opdivo®️ (nivolumab) andYervoy®️ (ipilimumab)。The immunotherapy drugs will be a first-line treatment forpleural mesothelioma patients无法接受手术。FDA批准来自治疗在大型临床试验期间改善患者生存的成功。
What Treatment Combination Did the FDA Approve?
The FDA-approved treatment结合Nivolumab和Ipilimumab。它是胸腔间皮瘤的成年人的一线治疗无法万博专业版进行手术。
Nivolumab和Ipilimumab分别以品牌名称Opdivo®️和Yervoy®销售。两个都免疫疗法药物检查点抑制剂。他们共同努力，帮助免疫系统定位，攻击和杀死癌细胞。
Promising Study Results for Mesothelioma Survival
The FDA approval源于成功的临床试验with 605 pleural mesothelioma patients. Researchers looked at patients treated with the immunotherapy combination compared to those用化疗治疗。
All patients in the study received no prior treatment. Their disease was also deemed unresectable. In other words, at the time of diagnosis, doctors were unable to remove their tumors with surgery.
研究人员试图确定哪种治疗选择表现出最大的存活率。
- First treatment option:每两周Opdivo®静脉注射一次。每六周静脉注射Yervoy®️。
- Second treatment option:Cisplatin or carboplatin and pemetrexed (chemotherapy combination) for up to six cycles.
治疗持续直到疾病进展，不可接受的毒性或两年的标记（以先到先得）。
*Results are from analysis at the minimum 22-month follow-up.
Similar Studies With Improved Survival
研究人员继续研究免疫疗法组合其他临床试验。Some studies focus on patient survival after treatment with only nivolumab compared to nivolumab and ipilimumab.
- MAPS-2 Study：用Nivolumab和IpiLimumab治疗时，中位生存率改善了四个月。与只有Nivolumab治疗相比，这与疗法相比。
- INITIATE Study: Median survival of greater than 12.7 months for those treated with both nivolumab and ipilimumab.
- 新研究：研究人员将在含Nivolumab治疗后看待生存，Nivolumab与Ipilimumab合并。然后，患者会进行手术，如果合适，可以继续进行化疗或辐射。
Were There Side Effects From the Treatment Combination?
Fromthe study of 605 pleural mesothelioma patients，包括副作用：
- Fatigue
- Musculoskeletal pain
- 皮疹
- Diarrhea
- 呼吸困难
- 恶心
- 胃口减少
- Cough
- Itching
Yervoy®️ could cause other immune-mediated side effects. This includes the inflammation of healthy organs, such as the lungs, colon, liver, endocrine glands or kidneys.
Patients should discuss all current and potential side effects with their medical care team.Palliative optionsare available to improve patient comfort and quality of life.
What Does the FDA Approval Mean?
临床试验为癌症对传统疗法无反应迟钝的患者提供额外的治疗方案。经过验证的成功，这些治疗可能会获得FDA批准。曾经批准后，治疗可能会广泛使用给其他患者。
胸腔间皮瘤的FDA批准的其他细节：万博专业版
- FDA批准了Bristol Myers Squibb公司的批准。
- FDA根据卓越的项目Orbis颁发的审查。
- 根据项目orbis，并发审查与澳大利亚，巴西，加拿大和瑞士的卫生官员举行。其他评论正在进行中。
- FDA在学习的目标日期前五个月批准了批准。
Researchers will continue studying and sharing the results of the immunotherapy treatment combination.
很少treatment options有FDA批准间皮瘤。万博专业版这只是批准治疗癌症的第二次全身疗法。因此，新的批准可以为许多胸膜间皮瘤患者提供希望。万博专业版
Patients should discuss all treatment options, including clinical trials, with amesothelioma specialist。Eligibility requirements differ from patient to patient. A specialist will be able to help patients determine which options match their specific case.
