Astellas Pharma Gets Positive CHMP Opinion For XTANDI In Early Prostate Cancer Treatment Setting

RTTNews | 435 dias atrás
Astellas Pharma Gets Positive CHMP Opinion For XTANDI In Early Prostate Cancer Treatment Setting

(RTTNews) - Astellas Pharma Inc. announced Friday the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDI (enzalutamide) 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.

The positive CHMP opinion is based on the results from the Phase 3 EMBARK trial.

The positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines in all 27 European Union (EU) member states as well as Iceland, Liechtenstein and Norway.

Astellas is also discussing the EMBARK data with other regulatory authorities to support additional license applications for XTANDI in this indication in 2024 and beyond.

Marcadores : ALPMY
read more
TSX Settles Lower As Trade Tensions Resurface

TSX Settles Lower As Trade Tensions Resurface

Despite hitting record highs earlier in the week, the Canadian market ended weak for a second straight day as trade tensions weighed on sentiment, prompting investors to tread cautiously on Friday.
RTTNews | 17h 31min atrás
Crude Oil Prices Slip On Friday

Crude Oil Prices Slip On Friday

Crude suffered a weekly loss of more than 1 percent due to uncertainty over U.S. President Donald Trump's tariffs and their likely impact on global growth and fuel demand.
RTTNews | 22h 10min atrás
Pound Drops As Trade Tensions Renew

Pound Drops As Trade Tensions Renew

The pound fell against its major counterparts in the New York session on Friday, as trade tensions escalated after the U.S. President accused China of violating trade agreement reached earlier this month.
RTTNews | 22h 11min atrás
Swiss Market Ends Modestly Higher

Swiss Market Ends Modestly Higher

Save for a few minutes at the start when it stayed a bit weak, the Switzerland market remained positive on Friday, and despite coming off the day's high hit around noon, ended the session modestly higher.
RTTNews | 1 dia atrás
Major European Markets Close Slightly Higher

Major European Markets Close Slightly Higher

Despite uncertainty surrounding Trump administration's tariff plans, The major European markets mostly closed higher on Friday. Trade tensions escalated after the U.S. President accused China of violating trade agreement reached earlier this month, but investors picked up stocks amid expectations of an interest rate cut by the European Central Bank.
RTTNews | 1 dia atrás