FDA
14th March 2018

FDA Advisory Committee Gives Amgen Green Light on New Indication for Blincyto®

On March 7th, 2018 the Oncologic Drugs Advisory Committee (ODAC) gathered to discuss supplemental biologic license application.

FDA Advisory Committee Gives Amgen Green Light on New Indication for Blincyto®

On March 7th, 2018 the Oncologic Drugs Advisory Committee (ODAC) gathered to discuss supplemental biologic license application (sBLA) 125557/S-013, for Blincyto ® (blinatumomab) injection for intravenous use via Amgen, Inc.  The panel discussed the proposed indication for the treatment of minimal residue disease-positive B-cell precursor acute lymphoblastic leukemia (MRD+ ALL). 

Amgen’s blinatumomab was awarded breakthrough therapy status as well as priority review designation and subsequently approved under FDA’s accelerated review program in 2014 for the treatment of relapsed or refractory B-cell precursor ALL in both adults and children. Blinatumomab belongs to a class of bi-specific T-cell engagers (BiTEs) monoclonal antibodies, which target the CD3 and CD19 binding sites of T and B-cells, respectively, which work to then elicit cytotoxic activity on the cancerous cell.

Amgen presented data from a phase 2 study (MT103-203), a single-arm study involving up to 4 cycles of blinatumomab, which resulted in 69 patients achieving complete MRD response within one cycle of blinatumomab. Following the sponsor presentation, participants from FDA noted that the 18-month relapse-free survival (RFS) rate was 56% and about 22 months.

Interestingly, the FDA did not request the panel directly vote on approval but instead asked if the available data demonstrate the for patients with ALL in complete remission (CR) who have MRD 0.1%, treatment with blinatumomab provides a potential benefit that outweighs the risks from the treatment. The panel largely supported Amgen’s proposed indication for MRD+ ALL, resulting in an 8-4 positive vote.

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