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ADCT: Binanggit ng FDA ang mga alalahanin sa benefit-risk sa pre-sBLA meeting ng LOTIS-5

The FDA expressed substantial concerns over the benefit-risk profile and verification of clinical benefit in the LOTIS-5 Phase 3 trial due to an imbalance in Grade 5 events and only marginal treatment benefit. As a result, ADC Therapeutics is now reassessing the regulatory path forward for ZYNLONTA to obtain full approval and advance into earlier lines of DLBCL, rather than proceeding directly to an sBLA submission.

Mahahalagang fact

Na-file
Ago 13, 2026, 01:14 PM
Kaganapan
Pagbabago sa trial registry
Direksyon
Negatibo
Kumpanya
ADCTADC Therapeutics
Asset
loncastuximab tesirine-lpyl
Pinagmulan
SEC 8-K
Kumpiyansa
May source

Sipi mula sa source

EX-99.1 2 dp251718_ex9901.htm EXHIBIT 99.1 Exhibit 99.1 ADC Therapeutics Reports Second Quarter 2026 Financial Results and Provides Operational Updates Second quarter 2026 net product revenue of $18.6 million; cash and cash equivalents of $219.1 million as of June 30, 2026 LOTIS-7, LOTIS-5 and MZL IIT data submitted for presentation at ASH Company evaluating regulatory path for ZYNLONTA ® to obtain full approval and advance into earlier lines of DLBCL following LOTIS-5 pre-sBLA meeting Company to host conference call today at 8:30 a.m. EDT LAUSANNE, Switzerland, August 13, 2026 – ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the second quarter ended June 30, 2026, and provided recent operational updates. ZYNLONTA ® commercial performance as a monotherapy in

SEC 8-K

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