Noofambar 2023: Under Project Renewal, an Oncology Centre of Excellence (OCE) initiative aimed at updating labelling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date, the Food and Drug Administration (FDA) approved updated labelling for temozolomide (Temodar, Merck). Under this experimental programme, this is the second medication to have its label updated. Capecitabine (Xeloda) was the first medication approved under Project Renewal.
Iyada oo loo marayo dadaalka wadajirka ah ee Cusbooneysiinta Mashruuca, saynisyahano xirfadda hore iyo khabiiro ku takhasusay kansarka dibadda ayaa falanqeynaya suugaanta la daabacay si loo helo waayo-aragnimada hore ee xulashada, daaweynta, iyo qiimeynta xogta dib u eegista madaxbannaan ee FDA. Hadafka Cusboonaysiinta Mashruucu waa in la joogteeyo summaynta ugu dambeysay ee daawaynta Kansarka ee da'da weyn, inta badan loo qoro iyada oo la kordhinayo aqoonta dadwaynaha ee calaamadinta daroogada isha macluumaadka iyo bixinta furfurnaanta shuruudaha caddaynta ee FDA iyo nidaamka qiimaynta.
Temozolomide hadda waa loo oggolaaday calaamadahan cusub iyo kuwa dib loo eegay:
- daawaynta adjuvant ee dadka qaangaarka ah ee dhawaan la helay anaplastic astrocytoma.
- daawaynta dadka waaweyn ee leh anaplastic astrocytoma refractory.
One approved indication for temozolomide remains the same:
- treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment.
Dib u eegisyada summeynta dheeriga ah waxaa ka mid ah:
- Habka qiyaasta dib ayaa loo eegay oo loo cusboonaysiiyay glioblastoma ee dhawaan la sheegay iyo anaplastic astrocytoma refractory.
- Kaabsaloyinka Temodar, macluumaadka khataraha ka iman kara kaabsoosha furan ayaa lagu daray Digniin iyo Taxaddar.
- Qaybta macluumaadka la-talinta bukaan-socodka iyo dukumeentiga macluumaadka bukaan-socodka waa la cusboonaysiiyay oo dib loo eegay.
