The At its meeting in February 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended extensions of the indications for four medicinal products:
Cemiplimab (Libtayo, Regeneron Ireland)
The antibody already conditionally approved for other cancers will also be indicated in the first-line treatment of NSCLC in combination with platinum-based chemotherapy in adult patients expressing PD-L1 (in ≥ 1% of tumor cells), without EGFR, ALK or ROS1 abnormalities, in the following disease stages
- locally advanced NSCLC if the patient is not a candidate for definitive chemotherapy radiotherapy
-
metastatic NSCLC
metastatic NSCLC
Pirfenidone (, Roche Registration)
The immunosuppressant is used in adults for the treatment of idiopathic pulmonary fibrosis, with the restriction to mild to moderate forms to be omitted in the future.
Human thrombin/human fibrinogen (TachoSil, Corza Medical)
The coagulation factor preparation is indicated for supportive treatment in surgery to improve haemostasis, promote tissue sealing and suture support in vascular surgery when standard techniques are not sufficient.So far, the use was limited to adult patients and will be extended in the future to children from the age of one month.
Upadacitinib (Rinvoq, AbbVie)
The selective immunosuppressant should also be indicated in the future for the treatment of adult patients with moderate to severe active Crohn’s disease who have responded inadequately to conventional therapy or a biological agent, no longer responded or showed intolerance.
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Source — https://www.univadis.de/viewarticle/chmp-meeting-indikationserweiterungen-f%25C3%25BCr-vier-2023a10004ed