dm+d

703684000

Medicine Compliance Aid Stability

XtandiAstellas Pharma Ltd

Astellas Pharma Ltd
Xtandi
Capsules 40mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Protect from moisture
Soft capsule.
18 September 2015

New Medicines

XtandiProstate cancer, metastatic hormone-sensitive in adult men - in combination with androgen deprivation therapy (ADT)

Information

Xtandi
Licence extension / variation
Astellas
Medivation

Development and Regulatory status

Launched
Launched
Launched
May 2021
May 21Approved in EU [10].
Mar 21Recommended for EU approval by CHMP - the additional indication is "the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) (see section 5.1)" [9].
Aug 20At their meeting in May, the EU CHMP discussed the application from Astellas to extend the licence for Xtandi to include treatment of hormone-sensitive PC. Previously the CHMP had asked for supplementary information in Oct 19, and in May, the CHMP adopted a 2nd request for supplementary information with a specific timetable (not made public). This will delay a decision on approval [8].
Dec 19Approved in US for metastatic castration-sensitive prostate cancer [7]
Aug 19Filed in US with priority review and in EU [6].
Jan 16PIII in EU & US [1].
Approved in UK [11]

Category

Androgen receptor antagonist
Prostate cancer (PC) is the most common male cancer in the UK, with more than 35,000 new cases diagnosed annually. In the UK, the incidence of PC is 97 per 100,000 people.
Prostate cancer, metastatic hormone-sensitive in adult men - in combination with androgen deprivation therapy (ADT)
Oral

Further information

Yes
To be confirmed

Trial or other data

Jul 19PIII ARCHES RCT (n=1,150) reports risk of radiographic progression or death was significantly reduced with enzalutamide plus androgen deprivation therapy (ADT) vs placebo plus ADT (median not reached vs 19.0 months HR 0.39; P<0.001)[5].
Jun 19Data from another international PIII randomised trial, ENZAMET (NCT02446405) reported at the American Society of Clinical Oncology annual meeting, led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group, back up the results from the company sponsored PIII ARCHES trial. Interim analysis found that 80% of men with metastatic hormone-sensitive prostate cancer (mHSPC) who received the non-steroidal anti-androgen (NSAA) enzalutamide (Xtandi) along with the standard of care treatment were alive after 3 years vs 72% of men who received one of the other three NSAAs along with standard treatment [4].
Feb 19Pfizer and Astellas announce positive data from PIII ARCHES Trial (n=1,150). Enzalutamide plus androgen deprivation therapy (ADT) significantly reduces risk of radiographic progression or death by 61% vs ADT alone (HR=0.39; 95% CI [0.30 to 0.50]; p<0.0001) [3].
Aug 18PIII ARCHES study (NCT02677896) is still recruiting patients and is due to complete collection of primary outcome data in Oct 18 [2].
Aug 17PIII ARCHES study (NCT02677896) is still recruiting patients. No change to predicted timelines [2].
Feb 16Feb 16: PIII study (NCT02677896) to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study will also evaluate the safety of enzalutamide plus ADT in mHSP. 1,100 men will be recruited from sites worldwide. Collection of primary outcome data is expected to complete Apr 20 [2].

Evidence based evaluations

XtandiProstate cancer in patients with non-metastatic hormone-sensitive disease with biochemical recurrence - in combination with leuprolide

Information

Xtandi
Licence extension / variation
Astellas
Medivation

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Androgen receptor antagonist
Prostate cancer (PC) is the most common male cancer in the UK, with more than 35,000 new cases diagnosed annually. In the UK, the incidence of PC is 97 per 100,000 people.
Prostate cancer in patients with non-metastatic hormone-sensitive disease with biochemical recurrence - in combination with leuprolide
Oral