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Get Ready For Amgen's PDUFA Date For BLINCYTO On September 1


BLINCYTO has suffered through a relatively soft launch, but things can rapidly change for the better in the coming months.

The FDA will most likely rule in Amgen's favor and make the drug available to children with acute lymphoblastic leukemia (ALL).

Another under-the-radar catalyst is an imminent National Comprehensive Cancer Network update that could happen at any timem recommending BLINCYTO for the Philadelphia chromosome-positive subtype of ALL.

In the first quarter, BLINCYTO earned a spot among the list of top drugs for Amgen, Inc. (NASDAQ:AMGN), one of the largest biotechnology companies with a market cap of $129.57 billion. BLINCYTO Q1 global sales cracked $25 million, but then merely increased 11% to $30 million in Q2. This was spurred by demand in Europe (since U.S. sales were flat) after Amgen gained marketing authorization for BLINCYTO in November for the treatment of Philadelphia chromosome-negative [Ph(-)] relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia ((B-ALL)). Suffice it to say that a lot hinges on the September 1 Prescription Drug User Fee Act target action date set by the Food and Drug Administration (FDA) to decide on the BLINCYTO supplemental Biologics License Application (sBLA) for pediatric use in the above indication.

Place in Therapy

BLINCYTO is the first approved bispecific T-cell engager ((BiTE)) antibody construct. BiTE molecules facilitate the linking of the body's T-cell response to tumor-associated antigens. BLINCYTO is bispecific to CD3 (important to T cell signaling) and CD19 (expressed ubiquitously in B-cell leukemias and lymphomas). Neurotoxicity and cytokine release syndrome (CRS) are dose-limiting and common; BLINCYTO has Black Box Warnings ((BBWs)) for these adverse events ((AEs)), either of which could be fatal. BLINCYTO may also affect all CD19+ cells, including normal cells such as nonmalignant B cells. Therefore, an increased risk in infections is a concern until BLINCYTO therapy is over and more B cell replacements are produced. On the other hand, it also follows that any B-cell malignancy outside of Ph(-) ALL or even nonmalignant conditions including autoimmune diseases are potential targets for the drug. There were initial trials in non-Hodgkin lymphoma (NHL), in which BLINCYTO showed activity. However, there were difficulties in finding the optimal administration and dose titration schedule, and the resulting complete response (CR) rates in patients with R/R diffuse large B-cell lymphoma weren't high enough to warrant inclusion as a treatment option by guideline makers.

Adults with R/R ALL have a very poor prognosis. The mutation of the Ph chromosome leads to expression of the Bcr-abl gene, which produces tyrosine kinase-like proteins that promote...