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

RTTNews | 509 дней спустя
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.

Тэгов: 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 | 691 дней спустя
European Economic News Preview: UK GDP & Foreign Trade Data Due

European Economic News Preview: UK GDP & Foreign Trade Data Due

Monthly GDP estimates and foreign trade from the UK and flash quarterly national accounts and employment from the euro area are due on Thursday. At 2.00 am ET, the Office for National Statistics releases UK GDP, industrial output and foreign trade data. The economy is forecast to grow 0.2 percent on a monthly basis in June, reversing a 0.1 percent fall in May.
RTTNews | 49 минут назад
Yen Rises Against Majors

Yen Rises Against Majors

The Japanese yen strengthened against other major currencies in the Asian session on Thursday.
RTTNews | 59 минут назад
Sensex, Nifty Marginally Higher Ahead Of US-Russia Talks

Sensex, Nifty Marginally Higher Ahead Of US-Russia Talks

Indian shares were marginally higher in early trade on Thursday, mirroring mostly positive cues from global markets ahead of the August 15 meeting between the U.S. President Donald Trump and his Russian counterpart Vladimir Putin.
RTTNews | 1ч 40мин назад
Australian Market Extends Early Gains In Mid-market

Australian Market Extends Early Gains In Mid-market

The Australian market is extending early gains in mid-market moves on Thursday, reversing the losses in the previous session, following the broadly positive cues from Wall Street overnight. The benchmark S&P/ASX 200 is moving up to near the 8,900 level to fresh all-time highs, with gains in mining, energy and financial stocks.
RTTNews | 2ч 28мин назад
Asian Markets Track Wall Street Higher

Asian Markets Track Wall Street Higher

Asian stock markets are trading mostly higher on Thursday, following the broadly positive cues from Wall Street overnight, on continued optimism over the outlook for interest rates, with the US Fed widely expected to lower rates by a least a quarter point next month. Asian markets closed mostly higher on Wednesday.
RTTNews | 3ч 0мин назад