Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms Imdylltra, Tarlatamab, AMG 757 + [4] |
Target |
Action stimulants, inhibitors |
Mechanism CD3 stimulants(T cell surface glycoprotein CD3 stimulants), DLL3 inhibitors(Delta-like protein 3 inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (16 May 2024), |
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Australia), Orphan Drug (Japan) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Small Cell Lung Cancer | Canada | 01 Sep 2024 | |
Extensive stage Small Cell Lung Cancer | United States | 16 May 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Small cell lung cancer limited stage | Phase 3 | United States | 23 Jan 2024 | |
Small cell lung cancer limited stage | Phase 3 | United States | 23 Jan 2024 | |
Small cell lung cancer limited stage | Phase 3 | Japan | 23 Jan 2024 | |
Small cell lung cancer limited stage | Phase 3 | Japan | 23 Jan 2024 | |
Small cell lung cancer limited stage | Phase 3 | Argentina | 23 Jan 2024 | |
Small cell lung cancer limited stage | Phase 3 | Argentina | 23 Jan 2024 | |
Small cell lung cancer limited stage | Phase 3 | Australia | 23 Jan 2024 | |
Small cell lung cancer limited stage | Phase 3 | Australia | 23 Jan 2024 | |
Small cell lung cancer limited stage | Phase 3 | Austria | 23 Jan 2024 | |
Small cell lung cancer limited stage | Phase 3 | Austria | 23 Jan 2024 |
Phase 1 | 41 | qffrafitzd = eruehmqhez nsloprcdlk (cpspjndjdj, xjpqnkgahg - qpzmahrutd) View more | - | 12 Sep 2025 | |||
Phase 2 | Small Cell Lung Cancer Third line | 31 | qljlsbttzz(bnefwxicok) = dhltpkdqut tinigyggrh (xwxetexbzo ) View more | Positive | 09 Sep 2025 | ||
Phase 3 | Recurrent Lung Small Cell Carcinoma Second line | 509 | cuzpzzotsp(nwpenancys) = hhdluwlqlw yfcgqfdcbo (nxwgvgaszh, 11.1 - not reached) | Positive | 24 Jul 2025 | ||
cuzpzzotsp(nwpenancys) = elmxisnipy yfcgqfdcbo (nxwgvgaszh, 7.0 - 10.2) | |||||||
Phase 3 | 509 | qwasctjyep(wmfivnhrop) = vncuisyggm watukxkdmj (cluhwhnjrn, 11.1 - NE) View more | Positive | 30 May 2025 | |||
qwasctjyep(wmfivnhrop) = egnrqhwbcy watukxkdmj (cluhwhnjrn, 7.0 - 10.2) View more | |||||||
Not Applicable | Recurrent Lung Small Cell Carcinoma Delta-Like ligand 3 | 31 | xnvnlwgncq(tflonyvqwd) = wyewjpfmni jghvtlumqr (aomekwxijl ) View more | Positive | 30 May 2025 | ||
Not Applicable | 24 | oidpkzlgvt(ztcgtwjcie) = yevpwotwrr ktzdxkzwgc (ndesyvfkuw ) View more | Positive | 30 May 2025 | |||
Placebo | wizctjkirx(bmmkjusxpk) = hnhpsiogis zknroattbf (wwthvgnbci ) View more | ||||||
Not Applicable | 185 | iswfbchvag(mepfcuwxjh) = CRS is the single most common AE reported (n=73,39.4%) followed by ICANS (n=48, 25.9%). 28% (n=21) of CRS patients were hospitalized and 25% (n=7) of them died. vomheidtyj (pwfmagnlpb ) View more | Negative | 30 May 2025 | |||
Not Applicable | 29 | luknburclx(bnzegifipc) = CRS was observed in 14 patients (grade 1: 7, grade 2: 4, grade 3: 3) dodwyqeaxg (pogjpthlyj ) View more | Positive | 30 May 2025 | |||
Phase 2 | - | ghwaxqlbbq(bifhxvqbzp) = 百济神州宣布其与安进公司(Amgen)在中国联合开展的注射用塔拉妥单抗(tarlatamab)2期临床研究DeLLphi-307已取得积极结果。 cvajvukjpz (ecaffaqofz ) | Positive | 26 May 2025 | |||
Phase 3 | - | kypyopowhy(kzbetibijt) = IMDELLTRA demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care (SOC) chemotherapy. hpgexwmpas (bzzffwbwnd ) Met | Positive | 11 Apr 2025 | |||
SOC |