US FDA grants earlier approval for Amgen’s Blincyto for rare form of lymphoblastic leukemia

Ahead of the anticipated decision date, the US Food and Drug Administration yesterday approved Blincyto (blinatumomab), an immunotherapy from USA-based Amgen (Nasdaq: AMGN), to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL. Amgen shares gained a modest 0.4% to $168.70 in after-hours trading.

"The FDA's breakthrough therapy designation and accelerated approval of Blincyto underscores the critical need for new treatment options for patients with relapsed or refractory B-cell precursor ALL, who are often young adults," said Sean Harper, executive vice president of R&D at Amgen, adding: "Blincyto is the first clinical and regulatory validation of the BiTE platform, a new and innovative approach that helps the body's own immune system fight cancer."

Amgen, the world’s largest independent biotech company, acquired Blincyto through the purchase of Germany-based biotech firm Micromet for $1.16 billion in 2012. Blincyto is an example of immunotherapy, a treatment that uses certain parts of a person’s immune system to fight diseases such as cancer. Blincyto is the first approved drug that engages the body’s T-cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. The drug acts as a connector between a protein called CD19, which is found on the surface of most B-cell lymphoblasts, and CD3, a protein on T-cell lymphocytes. It is intended for patients whose cancer returned after treatment (relapsed) or did not respond to previous treatment (refractory).