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Where will BDTX-1535 receive regulatory approval by September 30, 2025?
2
Resolution / Starting Odds
Only in the US • 25%
Only in the EU • 25%
In both US and EU • 25%
In US, EU, and Japan • 25%
Official announcements from regulatory agencies like FDA, EMA, PMDA, etc.
Story
Black Diamond Therapeutics Announces Initial Phase 2 Data for BDTX-1535 in Recurrent NSCLC with 42% ORR at 200 mg
Sep 23, 2024, 11:02 AM
Black Diamond Therapeutics has announced the initial Phase 2 data for its BDTX-1535 treatment in patients with recurrent EGFRm non-small cell lung cancer (NSCLC). The data, which will be presented in a webcast at today's 8am ET call, demonstrates robust anti-tumor activity. A 200 mg daily dose has been selected for pivotal development, showing a favorable tolerability profile. Preliminary overall response rate (ORR) of 42% was observed in 19 patients with on-target resistance EGFR mutations. The treatment is effective against a broad spectrum of classical, non-classical, and C797S resistance mutations.
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Yes • 50%
No • 50%
European Medicines Agency (EMA) • 25%
Health Canada • 25%
Japan's PMDA • 25%
Other • 25%
Phase 2 trial completion • 25%
Phase 3 trial initiation • 25%
Regulatory approval in any region • 25%
No significant milestone • 25%
FDA (USA) • 25%
EMA (Europe) • 25%
MHRA (UK) • 25%
Other • 25%
European Union • 25%
Japan • 25%
Canada • 25%
Other • 25%
Yes • 50%
No • 50%
Yes • 50%
No • 50%
Approved by FDA • 25%
Approved by EMA • 25%
Approved by both FDA and EMA • 25%
Not approved • 25%
Approved without conditions • 25%
Approved with conditions • 25%
Approval delayed • 25%
Not approved • 25%
Breakthrough Therapy Designation • 25%
Orphan Drug Designation • 25%
Priority Review • 25%
No additional designations • 25%
