Diskussion zu CytoSorbents Corporation (Seite 248)

[InsertName]

Antwort auf Beitrag Nr.: 55.635.158 von Aliberto am 31.08.17 10:04:25

Sorry, wenn das eine dumme Frage ist, aber ist das dann ein zu CTSO konkurrierendes Verfahren?

[Kleiner Chef]

Antwort auf Beitrag Nr.: 55.635.158 von Aliberto am 31.08.17 10:04:25

CAR-T_Cell Zulassung: Fast Track Status Cytosorb voraus?

Zitat von Aliberto: Novartis hat gestern die Zulassung für die CAR-T-Zellen Therapie in den USA erhalten und sehr sehr interessant sind neben der reinen Zulassung hier auch direkt die Ausfühungen der FDA bzgl. des Cytokine-Release-Syndroms und die Erweiterung der Zulassung für Actemra für mögliche Behandlung des CRS:

https://novartis.gcs-web.com/novartis-receives-fda-approval-…

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u…

daraus:

"......Treatment with Kymriah has the potential to cause severe side effects. It carries a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR T-cells causing high fever and flu-like symptoms, and for neurological events. Both CRS and neurological events can be life-threatening. Other severe side effects of Kymriah include serious infections, low blood pressure (hypotension), acute kidney injury, fever, and decreased oxygen (hypoxia). Most symptoms appear within one to 22 days following infusion of Kymriah. Since the CD19 antigen is also present on normal B-cells, and Kymriah will also destroy those normal B cells that produce antibodies, there may be an increased risk of infections for a prolonged period of time..........The FDA today also expanded the approval of Actemra (tocilizumab) to treat CAR T-cell-induced severe or life-threatening CRS in patients 2 years of age or older. In clinical trials in patients treated with CAR-T cells, 69 percent of patients had complete resolution of CRS within two weeks following one or two doses of Actemra..........Because of the risk of CRS and neurological events, Kymriah is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring that hospitals and their associated clinics that dispense Kymriah be specially certified. As part of that certification, staff involved in the prescribing, dispensing, or administering of Kymriah are required to be trained to recognize and manage CRS and neurological events. Additionally, the certified health care settings are required to have protocols in place to ensure that Kymriah is only given to patients after verifying that tocilizumab is available for immediate administration. The REMS program specifies that patients be informed of the signs and symptoms of CRS and neurological toxicities following infusion – and of the importance of promptly returning to the treatment site if they develop fever or other adverse reactions after receiving treatment with Kymriah...........To further evaluate the long-term safety, Novartis is also required to conduct a post-marketing observational study involving patients treated with Kymriah............"

http://edition.cnn.com/2017/08/30/health/fda-first-gene-ther…

@Alibert: Vielen Dank für das Update. Wenn Cytosorb den Fast Track Status erhalten sollte, dann wird Cytorobents uns sehr viel Freude bereiten, so meine Einschätzung.

Wie hoch ist Deine Prognose, daß Cytosorb den Fast Track Status erhalten wird?

Gruß

[Aliberto]

Novartis hat gestern die Zulassung für die CAR-T-Zellen Therapie in den USA erhalten und sehr sehr interessant sind neben der reinen Zulassung hier auch direkt die Ausfühungen der FDA bzgl. des Cytokine-Release-Syndroms und die Erweiterung der Zulassung für Actemra für mögliche Behandlung des CRS:

https://novartis.gcs-web.com/novartis-receives-fda-approval-…

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/u…

daraus:

"......Treatment with Kymriah has the potential to cause severe side effects. It carries a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR T-cells causing high fever and flu-like symptoms, and for neurological events. Both CRS and neurological events can be life-threatening. Other severe side effects of Kymriah include serious infections, low blood pressure (hypotension), acute kidney injury, fever, and decreased oxygen (hypoxia). Most symptoms appear within one to 22 days following infusion of Kymriah. Since the CD19 antigen is also present on normal B-cells, and Kymriah will also destroy those normal B cells that produce antibodies, there may be an increased risk of infections for a prolonged period of time..........The FDA today also expanded the approval of Actemra (tocilizumab) to treat CAR T-cell-induced severe or life-threatening CRS in patients 2 years of age or older. In clinical trials in patients treated with CAR-T cells, 69 percent of patients had complete resolution of CRS within two weeks following one or two doses of Actemra..........Because of the risk of CRS and neurological events, Kymriah is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring that hospitals and their associated clinics that dispense Kymriah be specially certified. As part of that certification, staff involved in the prescribing, dispensing, or administering of Kymriah are required to be trained to recognize and manage CRS and neurological events. Additionally, the certified health care settings are required to have protocols in place to ensure that Kymriah is only given to patients after verifying that tocilizumab is available for immediate administration. The REMS program specifies that patients be informed of the signs and symptoms of CRS and neurological toxicities following infusion – and of the importance of promptly returning to the treatment site if they develop fever or other adverse reactions after receiving treatment with Kymriah...........To further evaluate the long-term safety, Novartis is also required to conduct a post-marketing observational study involving patients treated with Kymriah............"

http://edition.cnn.com/2017/08/30/health/fda-first-gene-ther…

[Aliberto]

Antwort auf Beitrag Nr.: 55.562.371 von Aliberto am 20.08.17 15:24:17

Aktueller case-of-the-week beschreibt sehr schön, wie derzeit "noch" bei einer Sepsis in Deutschen Krankenhäusern vorgegangen wird und wann der Filter "erst" zum Einsatz kommt und dies hatte ich ja auch in Posting #1.755 unter Punkt 4 beschrieben und für mich festgestellt.

http://cytosorb-therapie.de/die-therapie/case-of-the-week/

[xxt]

Wie hoch seht ihr die Chancen an, dass es für Cytosorbents auch zu einem Übernahmeangebot kommen wird?

[Aliberto]

Antwort auf Beitrag Nr.: 55.612.223 von Aliberto am 28.08.17 16:02:53

https://www.bloomberg.com/news/articles/2017-08-28/epic-win-…

[Aliberto]

Im Bereich der "neuen" CAR-T-Zellen-Therapie hat Gilead Sciences heute die Übernahme von Kite Pharma verkündet:

http://www.marketwatch.com/story/gilead-to-buy-kite-pharma-f…

http://ir.kitepharma.com/releasedetail.cfm?ReleaseID=1038344

http://www.finanznachrichten.de/nachrichten-2017-08/41571126…

[Rainolaus]

Kurs scheint jetzt in einer engen Range gefangen zu sein drüben.

[Rainolaus]

Antwort auf Beitrag Nr.: 55.572.553 von Rogier am 22.08.17 08:47:33

Zitat von Rogier: Danke Aliberto fuer den og BEitrag.

Ich habe soeben eine Limitorder fuer 3,99eur aufgegeben.

wo denn? Ich sehe nichts.

[Rogier]

Danke Aliberto fuer den og BEitrag.

Ich habe soeben eine Limitorder fuer 3,99eur aufgegeben.