The FDA approval is based on the phase 3 BRUIN CLL-313 trial, in which 94% of patients responded to Jaypirca compared with 81% who received chemoimmunotherapy.
News|Articles|November 29, 2018
2018 FDA Advancements in Small Lymphocytic Leukemia
Author(s)Brielle Benyon
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Key Takeaways
- Venclexta plus Rituxan was approved for SLL and CLL patients with prior treatments, irrespective of 17p deletion status.
- Copiktra received FDA approval for relapsed or refractory SLL/CLL after two or more treatments, administered orally.
Take a look at the FDA’s decisions for the treatment of SLL that happened this year.
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The year 2018 was a busy one for the Food and Drug Administration (FDA) when it came to actions in the blood cancer space. There were three major advancements for the treatment of patients with small lymphocytic leukemia (SLL):
- Venclexta plus Rituxan. This combination was approved in June for patients with SLL — as well as chronic lymphocytic leukemia (CLL) – who have already had at least one other form of treatment. The drugs are given intravenously, and the combination is approved to treat patients regardless of whether or not they have a 17p deletion.
- Copiktra: In September, Copiktra (duvelisib) was granted FDA approval for patients with relapsed or refractory SLL or CLL who previously underwent two or more treatment options. Unlike Venclexta and Rituxan, Copiktra is given in pill form.
- Imbruvica plus Gazyva. The drug combination Imbruvica (ibrutinib) plus Gazyva (obinutizumab) was granted priority review in October, meaning that the FDA will review and potentially approve the regimen in six months instead of the usual 10. If approved, the duo will be used to treat patients in the frontline setting.
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