U.S. Markets closed
  • S&P 500

    3,693.23
    -64.76 (-1.72%)
     
  • Dow 30

    29,590.41
    -486.27 (-1.62%)
     
  • Nasdaq

    10,867.93
    -198.88 (-1.80%)
     
  • Russell 2000

    1,679.59
    -42.72 (-2.48%)
     
  • Crude Oil

    79.43
    -4.06 (-4.86%)
     
  • Gold

    1,651.70
    -29.40 (-1.75%)
     
  • Silver

    18.83
    -0.78 (-3.99%)
     
  • EUR/USD

    0.9693
    -0.0145 (-1.4733%)
     
  • 10-Yr Bond

    3.6970
    -0.0110 (-0.30%)
     
  • Vix

    29.92
    +2.57 (+9.40%)
     
  • GBP/USD

    1.0857
    -0.0398 (-3.5360%)
     
  • USD/JPY

    143.3300
    +0.9950 (+0.6991%)
     
  • BTC-USD

    18,942.64
    -236.51 (-1.23%)
     
  • CMC Crypto 200

    434.61
    -9.92 (-2.23%)
     
  • FTSE 100

    7,018.60
    -140.92 (-1.97%)
     
  • Nikkei 225

    27,153.83
    -159.30 (-0.58%)
     

FDA Approves Expanded Use For Bayer's Prostate Cancer Drug

·1 min read
  • The FDA approved Bayer AG's (OTC: BAYRY) supplemental marketing application for Nubeqa (darolutamide) with docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC).

  • The approval is based on the results of Phase 3 ARASENS trial that demonstrated a reduction in the risk of death by 32% in Nubeqa plus androgen deprivation therapy and docetaxel compared to ADT and docetaxel.

  • Nubeqa plus ADT and docetaxel also resulted in a statistically significant delay in time to pain progression.

  • The recommended darolutamide dose for mHSPC is 600 mg (two 300 mg tablets) taken orally, twice daily, with food until unacceptable toxicity or disease progression.

  • Docetaxel, 75 mg/m2 intravenously, is administered every three weeks for up to 6 cycles. The first dose of docetaxel should be administered within six weeks after starting darolutamide treatment.

  • In 2019, the FDA approved Nubeqa for non-metastatic castration-resistant prostate cancer (nmCRPC), receiving a concomitant gonadotropin-releasing hormone analog or analog had a bilateral orchiectomy.

  • Price Action: BAYRY shares closed lower by 7.09% at $13.63 on Friday.

See more from Benzinga

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.