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FDA 批準(zhǔn)新口服療法治療ALK-陽(yáng)性肺癌 已有1人參與
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在藥渡網(wǎng)看到的帖子，F(xiàn)DA又批準(zhǔn)新藥了，我們什么時(shí)候可以批準(zhǔn)呢？ 來(lái)源：藥渡網(wǎng) 美國(guó)FDA今天批準(zhǔn)Genentech 的Alecensa (alectinib)用于治療晚期 (轉(zhuǎn)移性) ALK-陽(yáng)性非小細(xì)胞肺癌 (NSCLC)，且患者病情已經(jīng)惡化，或不能再容忍目前的治療，該治療用藥為為Pfizer生產(chǎn)的 Xalkori (crizotinib)。 肺癌是癌癥死亡的主力軍，在美國(guó)，2015年估計(jì)新增 221,200 病例，158,040 會(huì)導(dǎo)致死亡。非小細(xì)胞肺癌是肺癌的最常見(jiàn)類(lèi)型。ALK(間變性淋巴瘤激酶) 基因突變可以發(fā)生在幾個(gè)不同類(lèi)型的癌癥細(xì)胞，包括肺癌細(xì)胞。目前，ALK 基因突變占據(jù)非小細(xì)胞肺癌5%左右。在轉(zhuǎn)移性癌中，這種疾病會(huì)蔓延到身體的新部位。針對(duì)ALK 陽(yáng)性非小細(xì)胞肺癌，大腦是疾病蔓延最常見(jiàn)的地方。 FDA 的藥物評(píng)價(jià)和研究中心血液學(xué)和腫瘤學(xué)辦公室主任Richard Pazdur, M.D.，說(shuō): '今天的批準(zhǔn)為一些已有的治療沒(méi)有任何起效（如一旦他們的疾病不再對(duì) Xalkori有任何反應(yīng)）的那群患者提供一種新療法'。'對(duì)于臨床醫(yī)生來(lái)說(shuō)，除了對(duì)肺腫瘤有較大影響外，Alecensa 臨床試驗(yàn)還對(duì)已經(jīng)擴(kuò)散到大腦的腫瘤起到一定效應(yīng)，這是非常重要的效果'。 Alecensa 是一種口服的藥物，阻止 ALK 蛋白的活性，某種意義上可以阻止非小細(xì)胞肺癌細(xì)胞的生長(zhǎng)和傳播。 在兩對(duì)臨床試驗(yàn)中參與者均是對(duì) Xalkori 治療不再起作用的轉(zhuǎn)移性 ALK 陽(yáng)性非小細(xì)胞肺癌患者。進(jìn)行了患者服用Alecensa 的療效及安全性的研究。研究參與者接受 Alecensa 每日兩次，測(cè)量其藥物對(duì)肺腫瘤的影響。在第一對(duì)臨床試驗(yàn)中，38%的參與者非小細(xì)胞肺癌腫瘤經(jīng)歷部分收縮的，這種效果持續(xù)了7.5 個(gè)月（平均）。在第二對(duì)研究中，44%的參與者非小細(xì)胞肺癌腫瘤經(jīng)歷部分收縮的，這種效果持續(xù)了11.2 個(gè)月（平均）。試驗(yàn)還研究了 Alecensa 對(duì)個(gè)人的腦轉(zhuǎn)移瘤的影響，這在該病群體中是一個(gè)普遍現(xiàn)象。這兩項(xiàng)試驗(yàn)中61%的參加者腦轉(zhuǎn)移瘤經(jīng)歷完全或部分的減少，這種效果持續(xù)了9.1 個(gè)月（平均）。 Alecensa 的最常見(jiàn)的副作用是疲勞，便秘，腫脹 (水腫) 和肌肉疼痛 (肌痛)。Alecensa 可能會(huì)導(dǎo)致嚴(yán)重的副作用，包括肝臟的問(wèn)題，嚴(yán)重或危及生命的肺炎癥、 心跳過(guò)緩和嚴(yán)重的肌肉問(wèn)題。接受Alecensa 治療的患者暴露于陽(yáng)光下，可能會(huì)導(dǎo)致曬傷。 Alecensa加速獲得批準(zhǔn)，同時(shí)FDA還授予突破性療法和優(yōu)先審查資格，再扣上一頂孤兒藥的帽子，可謂Genentech滿面春光。 |
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英文版： December 11, 2015 -- The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib). Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. An ALK (anaplastic lymphoma kinase) gene mutation can occur in several different types of cancer cells, including lung cancer cells. ALK gene mutations are present in about 5 percent of patients with NSCLC. In metastatic cancer, the disease spreads to new parts of the body. In ALK-positive NSCLC metastatic patients, the brain is a common place for the disease to spread. “Today’s approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to the primary effect on tumors in the lung, Alecensa clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important effect for clinicians to understand.” Alecensa is an oral medication that blocks the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading. The safety and efficacy of Alecensa were studied in two single-arm clinical trials of patients with metastatic ALK-positive NSCLC whose disease was no longer controlled by treatment with Xalkori. Study participants received Alecensa twice daily to measure the drug’s effect on their lung cancer tumors. In the first study, 38 percent of participants experienced a partial shrinkage of their NSCLC tumors, an effect that lasted for an average of 7.5 months. In the second study, 44 percent of participants experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months. The trials also examined Alecensa’s effect on individuals’ brain metastases, a common occurrence in this population. Sixty-one percent of participants in the two trials who had measurable brain metastases experienced a complete or partial reduction in their brain tumors, lasting an average of 9.1 months. The most common side effects of Alecensa are fatigue, constipation, swelling (edema) and muscle pain (myalgia). Alecensa may cause serious side effects, including liver problems, severe or life-threatening inflammation of the lungs, very slow heartbeats and severe muscle problems. Treatment with Alecensa may cause sunburn when patients are exposed to sunlight. Alecensa was approved using the accelerated approval regulatory pathway, which allows the FDA to approve products for serious or life-threatening diseases based on evidence that the product has an effect on an outcome that is reasonably likely to predict clinical benefit. In the case of Alecensa, the tumor response to treatment, along with the duration of response, provided this evidence. Under the accelerated approval requirements, a confirmatory study is required to verify and describe the clinical benefit of Alecensa. The FDA granted the Alecensa application breakthrough therapy designation and priority review status. These are distinct programs intended to facilitate and expedite the development and review of certain new drugs in light of their potential to benefit patients with serious or life-threatening conditions. Alecensa also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases. Alecensa is marketed by Genentech, based in San Francisco, California. Xalkori is marketed by Pfizer, based in New York, New York. Source: FDA Posted: December 2015 Related Articles: FDA Grants Genentech's Alectinib Priority Review for Specific Type of ALK-Positive Lung Cancer - September 8, 2015 Alecensa (alectinib) FDA Approval History |
2樓2015-12-15 23:07:04
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