Oncology

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The approval in CLL is supported primarily by data from a randomized, placebo-controlled phase 3 trial in combination with rituximab in 220 patients with relapsed CLL who were not able to tolerate standard chemotherapy. The approval in FL, is supported by data from a single-arm phase 2 study (Study 101-09) of Zydelig monotherapy in 125 iNHL patients refractory to rituximab and alkylating-agent-containing chemotherapy.

Although approved last September in the European Union, the National Institute for Health and Care Excellence had refused to cover the drug at the company-dictated price, which resulted in patients paying out-of-pocket.

The antibody, an inhibitor of the enzyme lysyl oxidase-like-2, combined with gemcitabine, did not have a significant effect on progression-free survival compared to the placebo with gemcitabine arm, in pancreatic cancer patients.

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