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Tevimbra (tislelizumab)

Region

🇪🇺 EU

Active substance

tislelizumab

Company

Beone Medicines Ireland Limited

Status

Authorised

Therapeutic area

Esophageal Squamous Cell Carcinoma; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Nasopharyngeal Carcinoma; Stomach Neoplasms

CHMP opinion

Thu 20 Jul 2023

EU approval

Fri 15 Sep 2023

Designations

Additional monitoring

Application

EMEA/H/C/005919

ATC

L01FF09

Official record

www.ema.europa.eu

Indication

Non-small cell lung cancer (NSCLC) Tevimbra, in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, is indicated for the treatment of adult patients with resectable NSCLC at high risk of recurrence (for selection criteria, see section 5.1).Tevimbra in combination with pemetrexed and platinum containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC  whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have: locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC. Tevimbra in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous NSCLC who have: locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC. Tevimbra as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab. Small Cell Lung Cancer (SCLC)Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC. Gastric or gastroesophageal junction (G/GEJ) adenocarcinomaTevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).Oesophageal squamous cell carcinoma (OSCC)Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD L1 with a TAP score ≥ 5% (see section 5.1).Tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic OSCC after prior platinum-based chemotherapy. Nasopharyngeal carcinoma (NPC)Tevimbra, in combination with gemcitabine and cisplatin, is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Tizveni Withdrawn · BeiGene Ireland Ltd

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.