New study supports FDA's decision to approve Copiktra (duvelisib)

Copiktra (duvelisib) is a new oral treatment option on the market for patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The medicine was approved by the US Food and Drug Administration (FDA) in September 2018.

The approval is supported by a recent Phase 3 trial that compares the new treatment, Copiktra (duvelisib), with the existing immunotherapy. The study showed that patients taking Copiktra (duvelisib) lived longer without disease progression: 13.3 months, compared to 9.9 months on the existing immunotherapy. There was also a higher response rate to Copiktra (duvelisib) of 73.8%, compared to 45.3% for the current immunotherapy.

Copiktra (duvelisib) inhibits two types of enzymes, phosphoinositide 3-kinase (PI3K) delta and gamma, which promote the growth and survival of cancerous immune system cells. This makes it the first dual inhibitor of PI3K-delta and PI3K-gamma to be approved by the FDA.

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