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ImmunityBio (IBRX) 股票上涨，FDA扩大ANKTIVA膀胱癌适应症批准

2026-10-15 08:11:04
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TLDR

FDA扩大ANTKIVA批准范围，惠及更多膀胱癌患者。临床结果支持ANTKIVA的扩展使用。ImmunityBio瞄准更大的膀胱癌市场。

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TLDR

ImmunityBio (IBRX) 股价上涨1.12%，报收于9.91美元，随着FDA扩大ANTKIVA对膀胱癌的批准，该股周三收盘上涨0.11美元，经历了一段波动交易后。在盘后交易中，该股进一步上涨0.81%，至9.99美元，该公司宣布了一项重大监管进展。FDA扩大了ANTKIVA的批准范围，包括患有无肌层浸润性膀胱癌（NMIBC）且对BCG无反应的乳头状肿瘤患者。

FDA扩大ANTKIVA对更多膀胱癌患者的批准

美国食品药品监督管理局（FDA）扩大了ANTKIVA与卡介苗（BCG）疗法联合使用的适应症。这一决定将仅患有乳头状肿瘤的患者纳入了该治疗方案的获批人群。

ImmunityBio现在可以向更多对BCG不再产生反应的膀胱癌患者提供这种联合治疗方案。

最新的决定紧随FDA于2024年4月对ANTKIVA的初步批准之后。当时的授权涵盖了伴有原位癌（CIS）、有或无乳头状肿瘤的BCG无反应性非肌层浸润性膀胱癌（NMIBC）患者。然而，早期的适应症排除了那些没有CIS但仅有乳头状疾病的患者。

这一扩展的适应症标志着FDA首次批准针对这一特定膀胱癌患者群体的治疗。ImmunityBio现在拥有ANTKIVA加BCG在CIS和乳头状疾病中的批准。此外，更广泛的标签增加了该治疗在美国膀胱癌市场的潜在覆盖范围。

临床结果支持ANTKIVA的扩展使用

FDA审查了支持ANTKIVA在治疗BCG无反应性膀胱癌方面的有效性的现有科学证据。这些证据包括ImmunityBio的QUILT-3.032临床试验A队列的结果。该试验评估了在伴有或不伴有乳头状肿瘤的CIS患者中使用ANTKIVA加BCG的效果。

在77名患者中，62%在临床研究期间达到了完全缓解。此外，58%的应答者维持其缓解状态至少12个月。另有40%的患者维持缓解状态至少24个月，证明了部分患者治疗的持续益处。

该治疗还显示出可管理的安全性特征，大多数报告的不良反应涉及膀胱相关症状。常见的反应包括排尿疼痛、尿频和血尿，大多为轻度或中度。然而，处方信息警告说，延迟膀胱切除术可能导致致命的转移性癌症的发展。

ImmunityBio瞄准更大的膀胱癌市场

非肌层浸润性膀胱癌约占美国膀胱癌诊断病例的80%。此外，估计85%至90%的新诊断NMIBC患者表现为乳头状疾病。这些数据突显了受该疾病影响的庞大患者群体。

当高级别乳头状肿瘤患者的癌症停止对BCG治疗产生反应时，他们面临重大风险。复发和疾病进展带来了额外的挑战，特别是对于寻求膀胱切除手术替代方案的患者。因此，扩展的批准为该组内的合格患者引入了另一种治疗选择。

ImmunityBio预计更广泛的适应症将使ANTKIVA的可触及美国市场超越其最初的CIS人群。公司还希望在2024年初次批准后继续推动商业增长。与此同时，最新的FDA决定加强了ImmunityBio在膀胱癌免疫治疗中的地位，并扩大了其潜在的商机。

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