Data uncertainties mean NICE does not recommend Roche leukemia drug

In yet another rejection of the company’s cancer drugs, the UK drugs watchdog, the National Institute for Health and Care Excellence (NICE), has issued new draft guidance for consultation that does not recommend National Health Service use of Swiss pharma major Roche’s (ROG: SIX) Gazyvaro (obinutuzumab) for untreated chronic lymphocytic leukemia (CLL).

In the preliminary guidance, uncertainties in the company’s data mean that the committee proposes not to recommend obinutuzumab combination therapy for people who are not able to take the standard fludarabine-based therapy.

Gazyvaro has been  approved by the European Commission in combination with chlorambucil chemotherapy for the treatment of previously untreated lymphocytic leukemia with co-morbidities making them unsuitable for an intensive therapy. Gazyvaro is marketed as Gazyva outside of the European Union and Switzerland.

Sir Andrew Dillon, NICE chief executive, said: “Chronic lymphocytic leukemia is the most common form of leukemia in the UK, with around 2,700 people being diagnosed with the condition each year. Half of the people who need treatment for their condition are not able to use the standard first-line therapy. NICE recommended alternative treatments are already available.”

Clinically effective but uncertainty of effective use of NHS resources