伊曲单抗治疗被批准用于治疗B细胞急性淋巴细胞白血病

07/18/17 (jkzx.com) – 美国食品和药物管理局（FDA）于2017年8月17日批准了用于治疗B细胞急性淋巴细胞白血病（ALL）的伊佐单抗奥佐霉素（Besponsa®）。 B细胞ALL携带费城染色体 – 一种遗传改变，使得疾病具有侵略性，难以治疗。

辉瑞制造的药物适用于一类B细胞ALL它对化学疗法具有耐药性或对化疗没反应的成年患者。这种药物的目的是使疾病得到控制，以便患者准备接受骨髓移植。

在INO-VATE ALL 3期临床试验中测试的药物能够使更多的患者获得缓解，或达到最小残留疾病（MRD）阴性状态，并为患者提供稍长的生存期。

具体来说，36％的用阿托珠单抗治疗的ALL患者完全缓解，其中90％为MRD阴性。在化疗患者中分别为17％和32％。

在使用伊曲单抗治疗的患者中，无进展生存期为5个月，化疗患者为1.9个月。伊托单抗治疗患者的总体生存期为7.7个月，化疗患者的总生存期为6.7个月。

用艾可单抗治疗的患者中有41％能接受骨髓移植，而化疗治疗的患者为11％。

跟化疗药物一样，伊曲莫单抗可诱发副作用，如感染，贫血，出血和恶心。它不能用于有肝病的病人。

Inotuzumab approved to treat B cell acute lymphoblastic leukemia

The U.S. Food and Drug Administration (FDA) on Aug 17, 2017 approved inotuzumab ozogamicin (Besponsa®) for treating B-cell acute lymphoblastic leukemia (ALL). B-cell ALL carries the Philadelphia chromosome – a genetic alteration that makes the disease aggressive and hard to treat.

The drug, made by Pfizer, is intended for adult patients whose B cell ALL has developed drug resistance to chemotherapy or became refractory and do not respond to standard chemotherapy.   The purpose of this drug is to get the disease under control so that the patients can be ready to receive bone marrow transplants.

The drug tested in the INO-VATE ALL phase 3 clinical trial was able to get more patients into remission, or achieve the minimal residual disease (MRD) negative status and provide patients with a slightly longer survival.

Specifically, 36% of B cell ALL patients treated with inotuzumab had a complete remission and 90% of these patients were MRD negative.  This is compared to 17% and 32%, respectively, in patients treated with chemotherapy.

The media progression-free survival was 5 months in patients treated with inotumumab and 1.9 months in patients treated with chemotherapy.   The overall survival was 7.7 months for inotumumab treated patients and 6.7 months for chemo-treated patients.

Forty one percent of patients treated with inotumumab were able to receive a bone marrow transplant, compared to 11% of patients treated with chemotherapy.

As chemotherapy drugs, inotumumab induced side effects such as infections, anemia, hemorrhage, and nausea.  And it should not be used in patients who had liver problems.