DA批准武田bortezomib（Velcade）用于套细胞淋巴瘤（MCL）初治群体
武田（Takeda）及旗下千禧制药（Millennium）10月9日宣布，FDA已批准Velcade（万珂，通用名：硼替佐米，bortezomib）注射液用于既往未经治疗（初治）的套细胞淋巴瘤（MCL）患者的治疗。
Velcade是首个获FDA批准用于初治MCL群体的药物。此前，FDA于2006年批准Velcade用于复发或难治性套细胞淋巴瘤（MCL）的治疗。此次批准，扩大了Velcade的适用群体。 套细胞淋巴瘤（MCL）是非霍奇金淋巴瘤的一种亚型，该病通常是一种极具侵略性的恶性肿瘤，复发风险高，因此是一种极具挑战性的难治愈性疾病。此前，FDA已批准多个靶向性药物，用于复发性或难治性MCL的治疗，但尚未批准任何药物用于初治MCL群体。 Velcade的获批，是基于一项国际性随机、头对头III期研究的数据。该项研究在既往未经治疗（初治）套细胞淋巴瘤（MCL）患者中开展，数据表明，与标准R-CHOP疗法（利妥昔单抗/环磷酰胺/阿霉素/长春新碱/泼尼松）治疗组相比，含Velcade的VcR-CAP疗法（Velcade/利妥昔单抗/环磷酰胺/阿霉素/强的松）治疗组无进展生存期（PFS）显著改善（25个月 vs 14个月，p＜0.0001），达到了研究的主要终点。此外，与R-CHOP治疗组相比，VcR-CAP治疗组有更多的患者实现完全缓解（CR：44% vs 34%）。 套细胞淋巴瘤（MCL）是一种罕见、恶性B细胞型非霍奇金淋巴瘤（NHL），常发生于老年人中。MCL约占非霍奇金淋巴瘤（NHL）病例的6%，该病通常起始于淋巴结，但可扩散至其他组织，如骨髓和肝脏。MCL患者的总生存期大约未4-5年，晚期MCL患者5年生存率约为50%。 今年8月，FDA已批准Velcade用于曾对万珂治疗有响应且完成最后一次万珂治疗后至少6个月后病情复发的多发性骨髓瘤（multiple myeloma，MM）成人患者的复治（retreatment，即再治疗）。在II期国际性RETRIEVE研究中，既往接受过Velcade治疗且经Velcade治疗取得部分缓解或完全缓解的多发性骨髓瘤（MM）患者群体，接受Velcade复治时的总缓解率（ORR）为38.5%。 在过去的11年里，Velcade作为唯一一种已被证明能够延缓新诊（newly diagnosed）或复发性多发性骨髓瘤（MM）患者总生存期（OS）的药物，在多发性骨髓瘤（MM）的临床治疗中发挥了重要作用。Velcade新获批的给药指南，将使医生能够为其Velcade经治患者继续提供这种有效的药物治疗，将Velcade用于多发性骨髓瘤的整个临床护理范畴。 关于万珂（Velcade）： Velcade由武田与强生联合开发，武田负责该药在美国的商业化，强生则负责药物在欧洲及世界其他地区的商业化，在日本，武田和强生联合推广该药。目前，Velcade已获全球90多个国家批准，经该药治疗的全球患者总数超过55万。 英文原文：FDA Approves VELCADE® (bortezomib) for Injection for Previously Untreated Patients with Mantle Cell Lymphoma ——This approval extends the benefit of VELCADE for mantle cell lymphoma (MCL) to previously untreated patients in addition to relapsed or refractory patients ——First treatment approved by the U.S. Food and Drug Administration for newly diagnosed MCL patients CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Millennium: The Takeda oncology Company with its parent company, Takeda Pharmaceutical Company Limited (TSE:4502), today announced that the U.S. Food and Drug Administration (FDA) has approved VELCADE® (bortezomib) for injection for use in previously untreated patients with mantle cell lymphoma (MCL). VELCADE is the first treatment in the United States to be approved for use in previously untreated patients with MCL. This approval extends the utility of VELCADE beyond relapsed or refractory mantle cell lymphoma, for which it has been approved since 2006. “Mantle cell lymphoma is a subtype of non-Hodgkin lymphoma that is usually a clinically aggressive malignancy, and it is a challenging disease to treat in part due to a relatively high risk of relapse,” said Andrew Evens, DO, MSc, Director, Tufts Cancer Center; Chief, Division of Hematology/Oncology; Director, Lymphoma Program. “There are several new targeted drugs approved by the FDA for patients with relapsed or refractory disease, but up to this point, there had been none approved for the treatment of patients with previously untreated disease. VELCADE, when used in the VcR-CAP regimen, VELCADE, rituximab, cyclophosphamide, doxorubicin and prednisone, has demonstrated improved outcomes for patients, making it an important advance for the treatment of newly-diagnosed patients with mantle cell lymphoma.” This approval is based on the results of an international, randomized, head-to-head Phase 3 study that showed that previously untreated patients receiving a VELCADE-containing combination (VcR-CAP) experienced a 59 percent relative improvement in the study’s primary endpoint of progression-free survival (PFS) compared to those who were administered the standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) regimen (median 25 vs. 14 months; Hazard Ratio [HR] 0.63; P<0.001) at a median follow up of 40 months. An Independent Review Committee (IRC) assessed the primary efficacy endpoint of PFS. The complete response (CR) rate for patients receiving VcR-CAP vs. R-CHOP was 44 percent vs. 34 percent. “We are delighted VELCADE has received approval in previously untreated mantle cell lymphoma. The VELCADE-combination delivered an 11-month median advantage in progression-free survival as compared to a current standard of care," said Dixie-Lee Esseltine, MD, FRCPC, Vice President, oncology Clinical Research, Takeda Pharmaceuticals International Co. "Since 2006, VELCADE has proven to be an important therapy for the treatment of relapsed or refractory mantle cell lymphoma, and it can now be used as an initial treatment for all patients with mantle cell lymphoma.” The open-label, multicenter, prospective study evaluated the efficacy and safety of VcR-CAP vs. R-CHOP in 487 patients with previously untreated MCL who were ineligible or not considered for a bone marrow transplant. VELCADE (1.3 mg/m2) is administered intravenously in combination with intravenous rituximab, cyclophosphamide, doxorubicin and oral prednisone (VcR-CAP) for six 3-week treatment cycles. VELCADE is administered first followed by rituximab. VELCADE is administered twice weekly for two weeks (days 1, 4, 8 and 11) followed by a 10-day rest period on days 12-21. For patients with a response first documented at cycle 6, two additional VcR-CAP cycles are recommended. At least 72 hours should elapse between consecutive doses of VELCADE. The most common adverse reactions occurring in ≥20 percent of patients receiving the VcR-CAP regimen were neutropenia, leukopenia, anemia, thrombocytopenia, lymphopenia, peripheral neuropathy, pyrexia, nausea and diarrhea. Infections were reported for 31 percent of patients in the VcR-CAP arm and 23 percent of the patients in the R-CHOP arm including pneumonia (8 percent versus 5 percent). Adverse reactions leading to discontinuation occurred in 8 percent of patients in the VcR-CAP arm and 6 percent of patients in the R-CHOP arm. In the VcR-CAP group, the most commonly reported adverse reaction leading to discontinuation was peripheral sensory neuropathy (1 percent; 3 patients). For additional important safety information, please see below. about Mantle Cell Lymphoma (MCL) MCL is a rare, aggressive type of B-cell non-Hodgkin lymphoma (NHL) that usually occurs in older adults. MCL constitutes about 6 percent of cases of NHL. The disease typically begins in the lymph nodes but can spread to other tissues, such as bone marrow and liver. The expected overall survival for MCL is approximately four to five years,and the five-year survival rate for advanced stage MCL is approximately 50 percent. about VELCADE® VELCADE® (bortezomib) is co-developed by Millennium/Takeda and Janssen Pharmaceutical Companies. Millennium is responsible for commercialization of VELCADE in the U.S.; Janssen Pharmaceutical Companies are responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in the U.S. for the treatment of mantle cell lymphoma (MCL) as well as in 53 additional countries for the treatment of patients with MCL who have received at least one prior treatment. VELCADE is also approved in more than 90 countries for the treatment of patients with multiple myeloma (MM) and has been used to treat more than 550,000 patients worldwide.
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