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Amgen Receives FDA Approval For BLINCYTO

Jul. 13, 2017 9:16 AM ETAmgen Inc. (AMGN)MRK3 Comments


  • BLINCYTO scores FDA approval for patients with relasped or refractory B-cell precursor acute lymphoblastic leukemia in adults and Children.
  • Market potential for BLINCYTO will expand.
  • Financials are in good order.
  • Combination studies between BLINCYTO and KEYTRUDA offer new opportunities.

Today, Amgen (NASDAQ:AMGN) announced that it had received FDA approval for its drug BLINCYTO. The FDA had approved the Supplemental Biologics License Application --sBLA-- for BLINCYTO, because of results from two positive clinical trials. The drug was approved because of results from a phase 3 study, known as the TOWER study. In addition, the company also included data from a phase 2 study, known as the ALCANTARA study, which was another reason for the approval.

Clinical Trial Results

Approval for BLINCYTO happened because of clinical results from the TOWER study. One thing to note with the link to the TOWER study is that it shows as being terminated. That is because the Data Monitoring Committee -- DMC -- recommended that the trial be terminated because the trial had met the primary endpoint. The trial recruited a total of 405 patients with Philadelphia Chromosome- negative relapsed/refractory B-cell precursor ALL -- acute lymphoblastic leukemia. The primary endpoint of the study was overall survival in patients between treatment with BLINCYTO compared to placebo. Patients that were treated with Amgen's drug achieved an overall survival rate of 7.7 months. That compares to those patients that were on placebo only achieving an overall survival rate of 4 months. That means that BLINCYTO was statistically significant over placebo with a p-value of p = 0.012. The FDA approval was also based on another study. The other study in question was a phase 2 clinical trial using BLINCYTO known as the ALCANTARA study. The patient population in this phase 2 trial is the same from the phase 3 trial noted above, but the primary endpoint was different. The primary endpoint for this trial looked at the possibility of patients achieving a complete response -- CR -- after two cycles of treatment with BLINCYTO. Of course, the phase 2 trial met the primary endpoint

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