dm+d

Unassigned

New Medicines

Prostate cancer, castration-resistant - first-line in combination with abiraterone

Information

New molecular entity
Roche
Roche

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Oct 22Development has been discontinued; no longer listed in Roche planned filings [14].
Sep 22Development of NICE TA suspended. Roche will no longer be pursuing a Marketing Authorisation Application in this indication at this time. The phase 3 trial (IPATential150) met its primary endpoint of rPFS in the PTEN-low/loss population however the magnitude of benefit was not considered sufficient for filing. Additional OS analysis was performed (IA2), which has not yet met statistical significance. Final OS analysis is anticipated mid-2023 but it is unlikely that the final analysis data will be any different from that observed at IA2 [13].

Category

Small molecule inhibitor of Akt
The age-standardised incidence of prostate cancer in the UK in 2014 was 175 per 100,000 population [1].
Prostate cancer, castration-resistant - first-line in combination with abiraterone
Oral

Further information

Yes

Evidence based evaluations