Roche's Gazyvaro Approved in Europe for Patients with the Most Common Type of Leukemia

Editor’s note: A new treatment for chronic lymphocytic leukemia (CLL) has been approved in Europe, meaning that oncologists in Europe can now start prescribing it to their patients. The treatment is specifically meant for people with CLL who have not yet been treated but who have other conditions that make them unable to use standard full-dose fludarabine-based treatment. The new treatment combines a drug called Gazyvaro with the chemotherapy drug chlorambucil. Gazyvaro is an immunotherapy drug, meaning that it boosts a patient’s own immune system to fight cancer.

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy). Outside of the EU and Switzerland, Gazyvaro is marketed as Gazyva.

“ ‘We are proud to make Gazyvaro available for CLL patients in Europe,’ said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. ‘Gazyvaro is a new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions.’ ”

“The European approval was based on the outcomes of the CLL11 study which was conducted in close collaboration with the German CLL Study Group. The study showed that Gazyvaro plus chlorambucil met its primary endpoint by significantly reducing the risk of disease worsening or death by 61% compared to MabThera/Rituxan plus chlorambucil (progression free survival; PFS). For patients in the Gazyvaro arm, median PFS was 26.7 months compared with 15.2 months for those in the MabThera/Rituxan arm (HR 0.39, CI 0.31-0.49, p<0.001).

“Additional Gazyvaro data from the CLL11 study showed higher complete response rates (21% compared with 7%) and a ten-fold increase in the percentage of people achieving minimal residual disease (MRD) negativity* (37.7% compared with 3.3%) compared to the MabThera/Rituxan arm of the study.”


FDA Approves Ofatumumab for Previously Untreated Chronic Lymphocytic Leukemia

“The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra) injection in combination with chlorambucil (Leukeran) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate.

The approval was based on the results of a multicenter, randomized, open-label trial comparing ofatumumab in combination with chlorambucil to single-agent chlorambucil.

Editor’s note: Once a newly developed drug has passed testing in clinical trials with volunteer patients, the U.S. Food and Drug Administration (FDA) decides whether to approve it, allowing doctors throughout the U.S. to prescribe it to patients with certain conditions. The FDA has now approved a new treatment for patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based treatment is not a good option. The new treatment combines a drug called ofatumumab (brand name Arzerra) with a drug called chlorambucil (Leukeran).


Phase II Study Suggests Benefit of Adding Rituximab to Chlorambucil in First-Line Treatment for Chronic Lymphocytic Leukemia

“In a UK phase II study reported in the Journal of Clinical Oncology, Hillmen et al assessed the safety and activity of adding rituximab (Rituxan) to chlorambucil (Leukeran) in first-line treatment of chronic lymphocytic leukemia (CLL). Such a regimen may be an alternative to fludarabine-based treatment or chlorambucil monotherapy in elderly patients and those with comorbidities.

“In the study, 100 patients in 12 UK centers received first-line rituximab (375 mg/m2 on day 1 of cycle 1 and 500 mg/m2 thereafter) plus chlorambucil (10 mg/m2 on days 1–7) for six 28-day cycles. Patients responding but not achieving complete response could receive an additional six cycles of chlorambucil alone.

“Patients had a median age of 70 years (range, 43–86 years) and a median of seven comorbidities, 66% were male, 56% had Binet stage C disease, 36% had IgVH mutation, and 13q deletion, 12q trisomy, 11q deletion, and 17p deletion were present in 43%, 16%, 13%, and 3%, respectively.”

Editor’s note: A new clinical trial with volunteer patients tested a treatment that combines the drug chlorambucil (Leukeran) with the drug rituximab (Rituxan). The treatment was found to be safe, and may be more effective than treatment with chlorambucil alone. This combination treatment might be a good option for people with chronic lymphocytic leukemia (CLL) who might not be able to take fludarabine-based treatment, especially elderly patients and patients with comorbidities (two or more diseases).