Health Canada approves ZYDELIG™ (idelalisib) for treatment of relapsed chronic lymphocyctic leukemia and conditionally approves ZYDELIG™ for follicular lymphoma.

April 8, 2015

Gilead Sciences Canada, Inc. announced that Health Canada has issued a Notice of Compliance for ZYDELIG (idelalisib) tablets in combination with rituximab for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). ZYDELIG also received a Notice of Compliance with Conditions as a monotherapy for the treatment of patients with follicular lymphoma (FL) who have received at least two prior systemic regimens and are refractory to both rituximab and an alkylating agent. ZYDELIG is a first-in-class inhibitor of PI3K delta, a protein that is over-expressed in many B-cell malignancies and plays a role in the survival, proliferation and migration of these cancer cells.

CLL and FL are slow-growing incurable lymphomas, most common in adults 50 years of age and older, that can lead to life-threatening complications such as anemia, serious infection and bone marrow failure requiring treatment. As conventional chemotherapy is not curative for CLL or FL, nearly all patients will eventually relapse after their initial treatment. At relapse, patients often face fewer treatment options because they may be unable to tolerate chemotherapy, or become resistant to treatment.

“Idelalisib offers an important treatment option for Canadians living with CLL and FL at the time of relapse,” said Dr. Carolyn Owen, Assistant Professor, Division of Hematology and Hematological Malignancies, Foothills Medical Centre, Calgary. “With these cancers, relapsed patients are often unable to tolerate traditional chemotherapy and thus, they require new active treatment options, particularly if several other therapies have failed. Many of these patients have previously had limited, if any, treatment options. We are now entering a new era of management of CLL patients. In the pivotal CLL clinical study, idelalisib demonstrated a statistically significant improvement in progression-free survival.”

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