Radium Ra223 dichloride
Radium Ra223 dichloride (Xofigo, Bayer AG) has 2 EU-approved indications in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Prostate cancer2 | |||
None | + LHRH analogue | Any line metastatic | Castration-resistant only; In progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment; Symptomatic bone metastases; no known visceral metastases |
None | Monotherapy | Any line metastatic | Castration-resistant only; In progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment; Symptomatic bone metastases; no known visceral metastases |
Full text of section 4.1 (therapeutic indications)
Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment (see section 4.4).
Label history
19 changes to the Xofigo label since 2015, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes