FDA Expands Approval Of Pfizer's Lorbrena As Treatment For ALK-Positive Metastatic Lung Cancer


2021-03-04 09:19:12 RTTNews


Pfizer Inc. said that the U.S. Food and Drug Administration approved its supplemental New Drug Application or sNDA for Lorbrena or lorlatinib, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase -positive non-small cell lung cancer or NSCLC. LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. The expanded approval of Lorbrena was based on the results from the pivotal Phase 3 CROWN trial, which showed a 72% reduction in risk of progression or death vs. XALKORI in a previously untreated patient population as assessed by blinded independent central review. Lorbrena is a third-generation ALK inhibitor specifically designed to inhibit the most common tumor mutations that drive resistance to current medications and to address metastases in the brain, a frequent site for disease progression in ALK-positive NSCLC. Up to 40% of people with ALK-positive metastatic NSCLC present with brain metastases at initial diagnosis. For comments and feedback contact: editorial@rttnews.com Business News
辉瑞公司表示,美国食品和药物管理局批准了其针对洛布瑞纳或洛拉替尼的补充新药申请或sNDA,将适应症扩大到包括间变性淋巴瘤激酶阳性非小细胞肺癌或NSCLC患者的一线治疗。LORBRENA现在用于FDA批准的检测结果显示ALK阳性的成人转移性NSCLC。 Lorbrena的扩大批准是基于关键的3期CROWN试验的结果,该试验显示,根据盲法独立中央审查评估,在以前未经治疗的患者群体中,与XALKORI相比,进展或死亡风险降低72%。 Lorbrena是第三代ALK抑制剂,专门设计用于抑制导致对当前药物产生耐药性的最常见的肿瘤突变,并处理脑转移,脑转移是ALK阳性NSCLC疾病进展的常见部位。高达40%的ALK阳性转移性NSCLC患者在最初诊断时出现脑转移。 如需评论和反馈,请联系:editorial@rttnews.com 商业新闻