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

RTTNews | 434 วันที่ผ่านมา
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.

แท็ก : ALPMY
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Merck Says Phase 3 KEYNOTE-A39/EV-302 Trial Meets Dual Primary Endpoints

Merck Says Phase 3 KEYNOTE-A39/EV-302 Trial Meets Dual Primary Endpoints

Merck & Co Inc. (MRK), known as MSD outside of the U.S. and Canada, announced Friday positive topline results from the Phase 3 KEYNOTE-A39 trial, which was conducted in collaboration with Seagen Inc. (SGEN) and Astellas Pharma Inc. (ALPMY.PK, ALPMY).
RTTNews | 616 วันที่ผ่านมา
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 | 2 ชม. 6 นาทีที่ผ่านมา
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 | 2 ชม. 30 นาทีที่ผ่านมา
Canadian Market Modestly Lower, Looks Headed For Another Weak Close

Canadian Market Modestly Lower, Looks Headed For Another Weak Close

The Canadian market is exhibiting weakness on Friday, weighed down by losses in energy, healthcare and technology sectors. Amid renewed concerns about a global trade war, the mood in the market remains cautious.
RTTNews | 3 ชม. 27 นาทีที่ผ่านมา
U.S. Stocks Broadly Lower In Cautious Trade

U.S. Stocks Broadly Lower In Cautious Trade

U.S. stocks are turning in a weak performance on Friday amid renewed concerns over trade tensions, and a batch of mixed economic data. The major averages all are down in negative territory, with the tech-laden Nasdaq underperforming.
RTTNews | 3 ชม. 59 นาทีที่ผ่านมา
Wall Street Likely To Open On Negative Note

Wall Street Likely To Open On Negative Note

Lower U.S. futures and uncertainty surrounding Trump administration's tariff moves point to a flat start for stocks on Wall Street on Friday. Investors will also be digesting some crucial economic data, including reports on U.S. consumer confidence, Chicago PMI reading, and personal income & spending reports.
RTTNews | 7 ชม. 22 นาทีที่ผ่านมา