Gilead Sciences has been granted marketing authorization by the European Commission for its Idelalisib 150mg tablets (to be marketed as Zydelig) to treat the two incurable blood cancers Chronic Lymphocytic Leukemia (CLL) and Follicular Lymphoma (FL). This formidable first-in-class oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, plays a key role in the activation, proliferation and viability of B cells, a critical component of the immune system.
The EU indications are similar, but not identical, to those in the U.S., where Idelalisib was approved in July 2014. For the treatment of CLL, the Idelalisib EU approval covers the use of Idelalisib combined with Rituximab for patients who have received at least one prior therapy (same as the US indication).
This Idelalisib EU approval was based mainly on a trial in 220 patients that was stopped early after it showed a significantly longer progression-free survival in patients receiving Idelalisib plus Rituximab. The results were published earlier this year in the New England Journal of Medicine. Researchers concluded that the addition of Idelalisib to Rituximab “provided effective durable disease control and improved overall survival for patients with relapsed CLL who were not suitable for cytotoxic chemotherapy, including high-risk patients.” Researchers also mentioned that treatment for CLL can be worse than the disease, leading to a great deal of side effects and death.
Idelalisib will be administered along with Rituximab for patients fighting refractory CLL. While there is a slight risk of serious toxicities, the majority of patients had common adverse reactions that were not deemed severe, and included pyrexia, abdominal pain, diarrhea, nausea and a mild rash. These adverse effects were seen in patients who were administered Idelalisib both with and without the addition of Rituximab.
Idelalisib is also EU approved to treat Follicular Lymphoma (FL) as monotherapy in patients who are refractory to two prior lines of treatment. This approval is supported by positive data from a phase 2 study of Idelalisib monotherapy in 125 patients.
The researchers concluded that Idelalisib “appears to provide effective oral monotherapy in patients with previously treated indolent non–Hodgkin’s lymphoma,” and these data were described as “eyebrow raising” when they were first presented at the 2103 American Society of Hematology meeting.
The advent of Idelalisib offers patients with these hard to treat forms of blood cancers better options for treatment and hope for tangible progression free survival. Idelalisib is also easy to administer as oral tablets which are typically taken twice daily, either with or without food. There are over 200,000 patients in the United States who suffer from relapsed follicular B-cell non-Hodgkin lymphoma, relapsed chronic lymphocytic leukemia or small lymphocytic lymphoma. This patient population is clearly in need of innovative and effective treatments.
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