Libtayo (cemiplimab)
- Region
- 🇪🇺 EU
- Active substance
- cemiplimab
- Company
- Regeneron Ireland Designated Activity Company (DAC)
- Status
- Authorised
- Therapeutic area
- Carcinoma, Squamous Cell
- CHMP opinion
- Fri 26 Apr 2019
- EU approval
- Fri 28 Jun 2019
- Application
- EMEA/H/C/004844
- ATC
- L01XC33
- Official record
- www.ema.europa.eu
Indication
Cutaneous Squamous Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation. Libtayo as monotherapy is indicated for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation (see section 5.1 for selection criteria). Basal Cell Carcinoma Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). Non-Small Cell Lung Cancer Libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ? 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Libtayo in combination with platinum?based chemotherapy is indicated for the first?line treatment of adult patients with NSCLC expressing PD-L1 (in ? 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. Cervical Cancer Libtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
Regulatory milestones
Libtayo (cemiplimab): DHPC sent to healthcare professionals
Quality defect; Carcinoma, Squamous Cell · source
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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.