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EC clears Zydelig

  • The European Commission approves Gilead Sciences' (NASDAQ:GILD) PI3K inhibitor Zydelig (idelalisib), 150 mg tablets, for the treatment of patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL).
  • For CLL, Zydelig is approved for use in combination with rituximab for patients who have received at least one prior therapy or as first-line treatment if the patient has a 17p deletion or TP53 mutation and is unsuitable for chemo-immunotherapy.
  • For FL, Zydelig is approved as a monotherapy in patients who are refractory to two prior lines of treatment.
  • GILD is up 1% premarket on light volume.
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