Having gained approval as a treatment for chronic lymphocytic leukemia earlier this year, the FDA has now extended Treanda's use to indolent B-cell non-Hodgkin's lymphoma. Although Treanda's total sales are set to increase following its approval in this more significant commercial market, Cephalon's drug is likely to face competition from pipeline drugs currently in late-stage development.
Approval of Treanda for non-Hodgkin's lymphoma (NHL) followed the results of a Phase III trial in which Treanda monotherapy was administered to 100 patients with indolent B-cell NHL who had been previously treated with Rituxan (rituximab; Biogen Idec/Genentech/Roche). In the single arm study the overall response rate was 74% (13% complete response rate). Duration of response was an average of 9.2 months in responders.
Treanda is an intravenously formulated alkylating agent and poly (ADP-ribose) polymerase (PARP) modulator. Although, it acts against dividing cells, its exact mechanism is unknown. Treanda was approved by the FDA for the treatment of chronic lymphocytic lymphoma (CLL) in March 2008 having been found to improve the progression-free survival by 12.4 months when compared with chlorambucil. Although Treanda is available in Germany for the treatment of CLL, it is not clear if further expansion into the EU markets is imminent.
Incidence of NHL in the seven major markets was 122,120 in 2007 with the US having the highest incidence rates. Treanda targets patients with indolent B-cell NHL. B-cell NHL is more prevalent than T-cell NHL, making up 78% of the population. Indolent B-cell NHL includes follicular lymphoma (FL), small cell lymphocytic lymphoma and MALT lymphoma which collectively make up about 33% of the total NHL population.
Zevalin (ibritumomab tiuxetan; Biogen Idec/Bayer Schering) and Bexxar (tositumomab; GlaxoSmithKline) represent two immunotherapy drugs that have already been approved by the FDA for the second-line treatment of FL. However, given the limited uptake of these treatments, a lack of standard of care in this indication remains. Treanda should succeed where Zevalin and Bexxar have struggled because it is easier to administer. It is therefore possible for Treanda to dominate the market for this sub population of patients and fulfill an unmet need in the NHL market.
However, Datamonitor expects competition to become fierce should late-stage drugs such as galiximab (Anti-CD80 MAb; Biogen Idec) and ofatumumab (HuMax-CD20; Genmab/GlaxoSmithKline) gain approval. It is likely that clinicians will prefer to use such targeted therapies due to the success of monoclonal antibody Rituxan in NHL compared to chemotherapy.