Astellas Pharma...announced the European Commission (EC) has approved a label extension for XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) 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

XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with:…castration-resistant prostate cancer….metastatic castration-sensitive prostate cancer.

Japanese pharma company Astellas has announced that its prostate cancer therapy Xtandi has gained an approval for an additional indication from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)....The additional indication is for once-daily oral Xtandi (enzalutamide) for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC).

Xtandi is indicated for:...the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC)….the treatment of adult men with metastatic castration resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the China National Medical Products Administration (NMPA) has approved XTANDI® (enzalutamide soft capsules) for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) with high risk of metastasis.

Astellas Pharma Canada, Inc., announced that Health Canada, following a Priority Review, has approved XTANDI (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

Astellas Pharma Inc...announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has approved XTANDI (enzalutamide), an oral androgen receptor signaling inhibitor, for the treatment of prostate cancer patients with distant metastasis.

Astellas Pharma Canada, Inc., today announced that Health Canada approved an expanded indication for enzalutamide, an androgen receptor inhibitor for the treatment of patients with prostate cancer, following a Priority Review by Health Canada's Therapeutic Products Directorate (TPD). With this designation, enzalutamide is now indicated to treat men with non-metastatic castration-resistant prostate cancer (nmCRPC), in addition to its existing indications for men with metastatic CRPC (mCRPC), making it a treatment option for both non-metastatic and metastatic CRPC patients.

Enzalutamide plus androgen deprivation therapy (ADT) is recommended, within its marketing authorisation, as an option for treating hormone-sensitive metastatic prostate cancer in adults.

Astellas’ oral treatment Xtandi has received approval from the National Institute for Health and Care Excellence (NICE) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

Apalutamide [ESMO-MCBS v1.1 score: 3], darolutamide [ESMO-MCBS v1.1 score: 3] or enzalutamide [ESMOMCBS v1.1 score: 3] should be considered as options for men with M0 (on bone scan and CT) CRPC and a high risk of disease progression [I, B].

Enzalutamide is a category 1 option for patients with M1 castration-naive prostrate cancer.

Pfizer...and Astellas Pharma...announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the companies' supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC; also known as non-metastatic hormone-sensitive prostate cancer or nmHSPC) with high-risk biochemical recurrence (BCR). The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists.

Pfizer...today announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI® (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR). Patients enrolled in the trial were randomized to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide.

Astellas Pharma...announced positive topline results from the Phase 3 China ARCHES study of XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) versus placebo plus ADT. The study met its primary endpoint, demonstrating a statistically significant improvement in time to prostate-specific antigen (PSA) progression (TTPP), defined as a ≥ 25% increase and an absolute increase of ≥ 2 µg/L (2 ng/mL) above the nadir (i.e., lowest PSA value observed post baseline or at baseline), which is confirmed by a second consecutive value at least 3 weeks later.

Median progression-free survival with enzalutamide was 9·5 months (95% CI 8·3–10·9) versus 8·3 months (6·3–8·7) with placebo (hazard ratio 0·72 [95% CI 0·53–0·96]; p=0·027)….PRESIDE met its primary endpoint and showed that continuing enzalutamide with docetaxel plus androgen deprivation therapy delayed time to progression compared with docetaxel plus androgen deprivation therapy alone...

Enzalutamide plus ADT reduced risk of death by 34%...Enzalutamide plus ADT continued to improve rPFS and other secondary end points….In conclusion, enzalutamide plus ADT significantly prolongs survival versus placebo plus ADT in patients with mHSPC.

Astellas Pharma Inc....announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending an additional indication for the oral once-daily therapy XTANDITM (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC)....The CHMP decision is based on data from the pivotal Phase 3 ARCHES trial investigating enzalutamide in men with mHSPC.

ENZA significantly prolonged OS compared with PBO (HR 0.73; 95% CI 0.61-0.89; P = .0011). Median OS was 67.0 mo (95% CI 64.0-not reached) in the ENZA arm and 56.3 mo (95% CI 54.4-63.0) in the PBO arm....This final OS analysis from PROSPER provides prospective validation of MFS as a potential surrogate endpoint for OS in nmCRPC and supports the continued use of ENZA + ADT as a standard of care in men with nmCRPC and rapidly rising PSA.

...in men with metastatic hormone-sensitive prostate cancer receiving testosterone suppression, the addition of enzalutamide resulted in longer overall survival, PSA progression-free survival, and clinical progression-free survival within 3 years than the use of standard nonsteroidal antiandrogen therapy.

...the risk of radiographic progression or death was significantly reduced with enzalutamide plus ADT versus placebo plus ADT (hazard ratio, 0.39; 95% CI, 0.30 to 0.50; P < .001; median not reached v 19.0 months)....Enzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC...