CatalystAlert

Search CatalystAlert

Search for companies, drugs, and catalysts

Search CatalystAlert

Search for companies, drugs, and catalysts

Back to AZNCF

Osimertinib 80 MG [Tagrisso]

Phase 2
ASTRAZENECA PLC (AZNCF)

Phase 2

Development Phase

0

Upcoming Catalysts

0

Historical Events

1

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Locally Advanced or Metastatic NSCLC

View Full Landscape
Drug Information

Target Indication

Locally Advanced or Metastatic NSCLC

Clinical Trial

NCT03414814

Last updated: 8/18/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA2/1/2016

Tagrisso

Tagrisso as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum‑based chemoradiation therapy. the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. Tagrisso is indicated in combination with: pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

Accelerated
View on EMA
Drug Science
Mechanism of action & safety profile
Get Catalyst Alerts
Receive weekly digests of upcoming catalysts

Weekly digest every Monday. Unsubscribe anytime.