Prostate cancer
The EU has approved 28 indications of 12 drugs in prostate cancer. 4 of them need a biomarker result: BRCA1/2 (3) and PSMA (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.
Castration status
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| BRCA1/2 mutation3 | ||||
Akeega | Germline and/or somatic BRCA 1/2 mutations | + prednisone or prednisolone | 1L metastatic | Castration-resistant only; Chemotherapy is not clinically indicated |
Lynparza | BRCA1/2 mutation (germline and/or somatic) | Monotherapy | 2L metastatic | Castration-resistant only; After prior therapy that included a new hormonal agent; Castration-resistant |
Akeega | Germline and/or somatic BRCA 1/2 mutations | + prednisone or prednisolone and androgen deprivation therapy (ADT) | Any line metastatic | Hormone-sensitive only |
| PSMA-positive1 | ||||
| + androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition | 3L+ metastatic | Castration-resistant only; After AR pathway inhibition and taxane-based chemotherapy; Progressive disease | ||
| No biomarker required24 | ||||
Firmagon | None | Monotherapy | Neoadj. | High-risk localised or locally advanced; hormone-dependent disease |
Zytiga, Abiraterone Krka | None | + prednisone or prednisolone | 1L metastatic | Castration-resistant only; Failure of androgen deprivation therapy; Asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated |
Zytiga, Abiraterone Krka | None | + prednisone or prednisolone, and androgen deprivation therapy (ADT) | 1L metastatic | Hormone-sensitive only; Newly diagnosed; high risk |
Xtandi | None | Monotherapy | 1L metastatic | Castration-resistant only; Failure of androgen deprivation therapy; Asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated |
Lynparza | None | + abiraterone and prednisone or prednisolone | 1L metastatic | Castration-resistant only; Chemotherapy is not clinically indicated; castration-resistant |
Talzenna | None | + enzalutamide | 1L metastatic | Castration-resistant only; Chemotherapy is not clinically indicated |
Zytiga, Abiraterone Krka | None | + prednisone or prednisolone | 2L metastatic | Castration-resistant only; Progressed on or after a docetaxel-based chemotherapy regimen |
Xtandi | None | Monotherapy | 2L metastatic | Castration-resistant only; Progressed on or after docetaxel therapy |
Erleada | None | + androgen deprivation therapy (ADT) | Any line metastatic | Hormone-sensitive only |
Erleada | None | Monotherapy | Any line locally adv. | Castration-resistant only; High risk of developing metastatic disease |
Nubeqa | None | + androgen deprivation therapy | Any line metastatic | Hormone-sensitive only |
Nubeqa | None | + docetaxel and androgen deprivation therapy | Any line metastatic | Hormone-sensitive only |
Nubeqa | None | Monotherapy | Any line locally adv. | Castration-resistant only; High risk of developing metastatic disease |
Firmagon | None | + radiotherapy | Any line | High-risk localised or locally advanced; hormone-dependent disease |
Firmagon | None | Monotherapy | Any line advanced | Hormone-dependent disease |
Xtandi | None | + androgen deprivation therapy | Any line locally adv. | Hormone-sensitive only; High-risk biochemical recurrent (BCR); unsuitable for salvage-radiotherapy |
Xtandi | None | + androgen deprivation therapy | Any line metastatic | Hormone-sensitive only |
Xtandi | None | Monotherapy | Any line locally adv. | Hormone-sensitive only; High-risk biochemical recurrent (BCR); unsuitable for salvage-radiotherapy |
Xtandi | None | Monotherapy | Any line locally adv. | Castration-resistant only; High-risk |
Camcevi | None | + radiotherapy | Any line | High-risk localised or locally advanced; hormone dependent |
Camcevi | None | Monotherapy | Any line advanced | Hormone dependent |
Xofigo | 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 |
Xofigo | 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 |
Orgovyx | None | Monotherapy | Any line advanced | Hormone-sensitive |
Tumour-agnostic approvals6
Approved for any solid tumour that carries the alteration, wherever the tumour started.
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| EpCAM1 | ||||
Korjuny | Monotherapy | 2L | Malignant ascites; not eligible for further systemic anticancer therapy | |
| HER21 | ||||
Enhertuconditional | HER2-positive (IHC 3+) | Monotherapy | 2L advanced | After prior treatment; No satisfactory treatment options |
| NTRK fusion3 | ||||
Rozlytrekconditional | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
Vitrakviconditional | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
Augtyroconditional | Monotherapy | Any line advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older | |
| RET fusion1 | ||||
Retsevmo | Monotherapy | Any line advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older | |
Biomarkers in prostate cancer
Label wording28
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Degarelix (Firmagon)
for treatment of adult male patients with advanced hormone-dependent prostate cancer.
- Degarelix (Firmagon)
for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
- Degarelix (Firmagon)
as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.
- Radium Ra223 dichloride (Xofigo)
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).
- Radium Ra223 dichloride (Xofigo)
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).
- Enzalutamide (Xtandi)
as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1).
- Enzalutamide (Xtandi)
as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1).
- Enzalutamide (Xtandi)
in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1).
- Enzalutamide (Xtandi)
for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).
- Enzalutamide (Xtandi)
for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).
- Enzalutamide (Xtandi)
for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
- Relugolix (Orgovyx)
Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.
- Leuprorelin (Camcevi)
CAMCEVI is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
- Leuprorelin (Camcevi)
CAMCEVI is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
- Niraparib + abiraterone (Akeega)
in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic).
- Niraparib + abiraterone (Akeega)
for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.
- Olaparib (Lynparza)
as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
- Olaparib (Lynparza)
in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1).
- Lutetium (177Lu) vipivotide tetraxetan (Pluvicto)
Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy (see section 5.1).
- Apalutamide (Erleada)
in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).
- Apalutamide (Erleada)
in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) (see section 5.1).
- Abiraterone (Zytiga, Abiraterone Krka)
the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)
- Abiraterone (Zytiga, Abiraterone Krka)
the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)
- Abiraterone (Zytiga, Abiraterone Krka)
the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
- Talazoparib (Talzenna)
Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
- Darolutamide (Nubeqa)
- non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).
- Darolutamide (Nubeqa)
- metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).
- Darolutamide (Nubeqa)
- metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).