The US Food and Drug Administration is to give US biotechnology groups Genentech and Biogen Idec’s Rituxan (rituximab) a priority review for the treatment of aggressive, previously-untreated non-Hodgkin’s lymphoma.
This means that the agency has six months to reach a decision on whether to clear the drug for this expanded indication and, as the application was initially filed in August [[18/08/05f]], a ruling is expected in February. Investors welcomed the news, with shares in Biogen closing up 1.9% at $40.24 and Genentech stock rising 1.6% to close at $88.37 on October 25.
Rituxan first received FDA approval in November 1997 for relapsed or refractory low-grade, B-cell non-Hodgkin's lymphoma, and the companies are now seeking expanded approval of the agent as a first-line therapy, in combination with chemotherapy, for patients with aggressive forms of the condition, which affects around half of the 360,000 NHL patients in the USA. In addition, the agent is currently being evaluated for the treatment of rheumatoid arthritis and other autoimmune diseases such as lupus and multiple sclerosis [[01/09/05f]].
The agent already brings in significant revenues for Genentech, which saw Rituxan turnover jump 16% to $456 million in the third quarter [[11/10/05a]], while its European partner Roche, holder of rights to the drug in Europe and the rest of the world, saw sales cap 3 billion Swiss francs ($2.3 billion) marking growth of just under 25% over the year-ago period [[19/10/05b]].
Meanwhile, Swiss drugmaker Roche has unveiled initial data from a Phase III clinical trial showing that the drug, marketed as MabThera by the group, is effective as a maintenance therapy in patients with relapsed indolent NHL.
“Our study confirms that MabThera maintenance therapy is beneficial for patients that have already received MabThera as part of their initial therapy,” stated lead study investigator, Professor Marinus van Oers from the Academic Medical Center of the University of Amsterdam, noting that full results will be presented at the American Society of Hematology conference in Atlanta later this year.
Commenting on the results and the drug’s potential, Eduard Holdener, Head of Pharma Development at the drug giant, claimed: “Based on this new information, MabThera maintenance therapy could well become the new standard treatment in this disease.”
Roche said it is currently preparing an application to the European Authorities to request a label extension for maintenance therapy, which is scheduled for submission in the fourth quarter 2005, making this treatment option available to all patients.