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

RTTNews | 401 ngày trước
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.

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European Shares Seen Opening Up In Cautious Trade

European Shares Seen Opening Up In Cautious Trade

European stocks are likely to open on a steady note Monday after U.S. stocks posted their longest advance in three months on Friday amid signs of easing trade tensions and bets the Federal Reserve will cut interest rates as early as June, as the American economy softens.
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Sensex, Nifty Follow Global Peers Higher

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Indian shares were trading higher on Monday, tracking firm cues from global markets. The benchmark S&P/BSE was up 548 points, or 0.7 percent, at 79,760 despite rising tensions between India and Pakistan, triggered by the Pahalgam terror attack.
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Australian Market Trims Early Gains In Mid-market

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The Australian stock market is trimming its early gains in mid-market trading on Monday, adding to the gains in the previous two sessions, following the broadly positive cues from Wall Street on Friday. The benchmark S&P/ASX 200 index is moving well above the 8,000.00 mark, with gains technology, energy and financial stocks partially offset by weakness in mining stocks.
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Asian Markets Track Wall Street Higher

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Thai Stock Market May See Additional Support On Monday

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The Thai stock market bounced higher again on Friday, one day after ending the two-day winning streak in which it had gained almost 20 points or 1.8 percent. The Stock Exchange of Thailand now sits just beneath the 1,160-point plateau and it's expected to extend open in the green again on Monday.
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