Rituxan gains approval for most common leukaemia
pharmafile | February 19, 2010 | News story | Sales and Marketing | FDA, MabThera, Rituxan, blood cancer
Roche’s blockbuster cancer treatment MabThera/Rituxan has been approved by the FDA for the treatment of adult leukaemia.
The drug earned Roche $5.6 billion in revenues last year, based on its numerous licensed indications including Non-Hodgkin’s lymphoma.
Now the drug is set to extend its reach further, and could offer patients with chronic lymphocytic leukaemia (CLL) significantly longer survival.
CLL is the most common form of adult leukaemia and accounts for around 30-40% of leukaemia cases in Western countries and is currently deemed incurable.
The treatment aim is to control the disease and extend patient life expectancy with progression-free survival.
Rituxan (rituxmab) will be used as either previously untreated (first-line) patients or previously treated (relapsed or refractory) CD20-positive chronic lymphocytic leukaemia (CLL) alongside fludarabine and cyclophosphamide (FC) chemotherapy.
Phase III studies presented in December 2009 showed patients with CLL treated with Rituxan plus chemotherapy live significantly longer without their disease progressing compared with those treated with chemotherapy alone. 87.2% of patients with previously untreated CLL who received Rituxan plus FC were alive after more than three years of follow up (37.7 months) compared to 82.5 percent of patients who received FC alone.
The drug was approved in Europe (where it is known as MabThera) for first-line and relapsed and refractory CLL last year, and gained approval from UK cost effectiveness body NICE in July 2009.
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