U.S. markets open in 8 hours 40 minutes
  • S&P Futures

    4,241.25
    +9.75 (+0.23%)
     
  • Dow Futures

    33,849.00
    +90.00 (+0.27%)
     
  • Nasdaq Futures

    14,299.75
    +36.75 (+0.26%)
     
  • Russell 2000 Futures

    2,308.10
    +7.80 (+0.34%)
     
  • Crude Oil

    73.14
    +0.06 (+0.08%)
     
  • Gold

    1,774.40
    -9.00 (-0.50%)
     
  • Silver

    25.91
    -0.20 (-0.77%)
     
  • EUR/USD

    1.1929
    -0.0004 (-0.04%)
     
  • 10-Yr Bond

    1.4870
    0.0000 (0.00%)
     
  • Vix

    16.32
    -0.34 (-2.04%)
     
  • GBP/USD

    1.3962
    -0.0002 (-0.01%)
     
  • USD/JPY

    110.9670
    +0.0050 (+0.00%)
     
  • BTC-USD

    32,617.96
    -1,343.47 (-3.96%)
     
  • CMC Crypto 200

    788.12
    -22.07 (-2.72%)
     
  • FTSE 100

    7,074.06
    -15.95 (-0.22%)
     
  • Nikkei 225

    28,864.28
    -10.61 (-0.04%)
     

Oncologic Drugs Adcomm Backs Merck's Keytruda, Roche's Tecentriq Accelerated Approvals In Bladder Cancer

  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
·1 min read
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • The FDA’s Oncologic Drugs Advisory Committee voted 5-3 in favor of keeping Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) accelerated approval alive as a first-line bladder cancer treatment, even after a Merck confirmatory trial failed.

  • While the confirmatory trial did not show a benefit for Keytruda as a first-line treatment, much of the discussion centered on these subgroups of patients who might have no treatment options without Keytruda.

  • The current nod allows Keytruda to be used in previously untreated patients who are cisplatin-ineligible and carboplatin-ineligible. It’s also approved for those who aren’t eligible for any platinum chemo, regardless of their PD-L1 status.

  • Also, ODAC voted 10-1 in favor of keeping Roche Holdings AG’s (OTCMKTS: RHHBY) Tecentriq (atezolizumab) as a first-line treatment of cisplatin-ineligible patients with advanced/metastatic bladder cancer pending final overall survival results from a confirmatory trial, known as IMvigor130.

  • On Tuesday, the committee members voted 7-2 to keep alive the accelerated approval for Tecentriq plus Abraxane (nab-paclitaxel) in metastatic triple-negative breast cancer while additional confirmatory trials are ongoing.

  • FDA Briefing Documents here.

  • Price Action: MRK shares are down 5.15% at $73.12, and RHHBY is down 0.58% at $41.26 on the last check Thursday.

See more from Benzinga

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.