MEDIA RELEASE • COMMUNIQUE AUX MEDIAS • MEDIENMITTEILUNG
Glivec ® recommended for use in Europe as first post-surgery treatment for gastrointestinal stromal tumors (GIST) • Use of Glivec after surgery (adjuvant setting) shows substantial benefit for GIST patients, reducing risk of recurrence by 89%1 • GIST, a life-threatening cancer, recurs in as many as...
| Other Authors: | |
|---|---|
| Format: | Text |
| Language: | English |
| Subjects: | |
| Online Access: | http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.627.7 http://hugin.info/134323/R/1299087/296219.pdf |
| Summary: | Glivec ® recommended for use in Europe as first post-surgery treatment for gastrointestinal stromal tumors (GIST) • Use of Glivec after surgery (adjuvant setting) shows substantial benefit for GIST patients, reducing risk of recurrence by 89%1 • GIST, a life-threatening cancer, recurs in as many as one out of two patients2 • Positive opinion for Europe follows recent approvals of Glivec in the adjuvant setting in the US and Switzerland Basel, March 19, 2009 – Novartis has received a positive opinion supporting European Union (EU) approval of Glivec ® (imatinib) * as a post-surgery treatment for patients at significant risk of relapse following removal of gastrointestinal stromal tumors (GIST). The Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Glivec based on positive findings from a pivotal Phase III study, which showed that use of Glivec after surgery reduces risk of recurrence by approximately 89%1. The European Commission generally follows the recommendations of the CHMP and delivers its final decision within two to three months. The decision will apply in all 27 EU member states plus Iceland and Norway. “This positive opinion is an important step forward for GIST patients, ” said David Epstein |
|---|