The FDA announced Breakthrough Therapy Designation (BTD) for acalabrutinib (Calquence) as a single agent to treat chronic lymphocytic leukemia (CLL)
Two weeks ago, Gilead provided the following statement:
At Gilead, patient safety is our highest priority and we continuously monitor safety information about our medicines to inform their appropriate use. A review of ongoing Zydelig (idelalisib) Phase 3 studies found an increased risk of serious adverse events and death, generally due to infections, in patients receiving Zydelig for first-line treatment of chronic lymphocytic leukemia (CLL) and relapsed indolent NHL (iNHL).
As a result of this new information, we are proactively terminating several ongoing studies in first line CLL and iNHL and relapsed iNHL and conducting a comprehensive review of all ongoing studies. Gilead believes that Zydelig is an important treatment option for relapsed CLL and refractory follicular lymphoma and small lymphocytic lymphoma patients who generally have limited effective therapeutic options, and we are consulting with regulatory authorities on next steps.
The FDA has issued the following drug warning about idelalisib or Zydelig.
On March 21, 2016, Gilead provided more details to healthcare providers in the United States. See the details here.
We will provide more background soon on what this means for those currently being treated with idelalisib or considering it.
March 24,2016
Related posts
