Catatan sumber primer
PenentuPerubahan registri uji klinis
ADCT: FDA menandai kekhawatiran manfaat-risiko dalam pertemuan pra-sBLA LOTIS-5
FDA menyatakan kekhawatiran substansial terkait profil manfaat-risiko dan verifikasi manfaat klinis dalam uji coba Fase 3 LOTIS-5 karena ketidakseimbangan kejadian Grade 5 dan manfaat pengobatan yang hanya marginal. Akibatnya, ADC Therapeutics kini sedang menilai ulang jalur regulasi ke depan untuk ZYNLONTA guna memperoleh persetujuan penuh dan maju ke lini pengobatan DLBCL yang lebih awal, daripada melanjutkan langsung ke pengajuan sBLA.
Fakta utama
- Diajukan
- 13 Agu 2026, 13.14
- Peristiwa
- Perubahan registri uji klinis
- Arah
- Negatif
- Perusahaan
ADCTADC Therapeutics- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
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