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

RTTNews | 242 days ago
Stocktwits
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.

Tags: ALPMY
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U.S. Housing Starts Tumble 3.1% In October, More Than Expected

U.S. Housing Starts Tumble 3.1% In October, More Than Expected

New residential construction in the U.S. tumbled by more than expected in the month of October, according to a report released by the Commerce Department on Tuesday. The report said housing starts dove by 3.1 percent to an annual rate of 1.311 million in October after slumping by 1.9 percent to a revised rate of 1.353 million in September.
RTTNews | 5h 15min ago
Eurozone Inflation Rises To 2% As Estimated

Eurozone Inflation Rises To 2% As Estimated

Eurozone inflation returned to the 2 percent target in October, final data from Eurostat showed on Tuesday. The harmonized index of consumer prices climbed as initially estimated in October after rising 1.7 percent in September. Core inflation that excludes prices of energy, food, alcohol and tobacco, remained unchanged at 2.7 percent in October.
RTTNews | 6h 33min ago
Euro Slides Against Majors

Euro Slides Against Majors

The euro weakened against other major currencies in the European session on Tuesday, as traders are worried that protectionist policies by President-elected Donald Trump could disrupt the Eurozone's growth potential.
RTTNews | 7h 3min ago
FTSE 100 Slips As Geopolitics Weighs

FTSE 100 Slips As Geopolitics Weighs

The FTSE 100 benchmark of the London Stock Exchange aligned with the trend in European markets to trade in the red amidst a massive spike in geopolitical concerns. However, the index managed to outperform its European peers.
RTTNews | 7h 8min ago
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