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

RTTNews | vor 510 Tagen
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.

read more
CAC Rises For 3rd Straight Session

CAC Rises For 3rd Straight Session

French stocks are gaining ground in positive territory on Thursday, rising for the third consecutive session, amid hopes of an interest rate cut by the Federal Reserve next month, and expectations that the upcoming meeting between U.S. President Donald Trump and Russian President Vladimir Putin will help end the war in Ukraine.
RTTNews | vor 17 Minuten
Eurozone GDP Rises 0.1% As Estimated

Eurozone GDP Rises 0.1% As Estimated

The euro area economy grew at a marginal pace in the second quarter as initially estimated, and companies generated jobs modestly, official data showed on Thursday. Another data from Eurostat showed that industrial production remained weak in the second quarter as the positive impact from frontloading of orders from the US faded.
RTTNews | vor 29 Minuten
DAX Modestly Higher As Investors Focus On Earnings

DAX Modestly Higher As Investors Focus On Earnings

The German market is up in positive territory on Thursday, extending gains from the previous session, with investors continuing to focus on earnings and economic data, and hoping for an interest rate cut by the Federal Reserve next month. Focus is also on the upcoming meeting between U.S. President Donald Trump and Russian President Vladimir Putin.
RTTNews | vor 1Std 6 Minuten