FDA Gives Nod To Roche’s Rituxan

Rituxan is intended for patients with CLL who are beginning chemotherapy for the first time and for those who have not responded to other cancer drugs for CLL. It is administered with two other chemotherapy drugs, Fludarabine and Cyclophosphamide. Rituxan binds to the surface of cancer cells, making it easier for the patient’s immune system to attack the cancer cell as if it were a foreign pathogen.

The safety and effectiveness of Rituxan was evaluated in two studies that measured progression-free survival, defined as the time a patient in the study lived without the cancer progressing.

Reportedly, in one study of 817 patients who had not received any prior chemotherapy, progression-free survival was eight months longer for those receiving Rituxan plus chemotherapy than for those who received chemotherapy alone.

Additionally, in another study of 522 persons whose cancer had progressed following other chemotherapy drugs, progression-free survival was five months longer for those who received Rituxan plus chemotherapy.

FDA has analysed the data on patients 70 years of age and older who had received Rituxan and found no evidence that adding the drug to chemotherapy benefited elderly patients compared to receiving chemotherapy alone. However, there was also no evidence that Rituxan was harmful to elderly patients.

The study results showed, a decrease in infection-fighting, normal white blood cells was also commonly observed in patients enrolled in the Rituxan clinical trials.

Richard Pazdur, director, office of oncology drug products in the center for drug evaluation and research at FDA, said: “Rituxan is the third drug approved for the treatment of CLL since 2008 and underscores FDA’s commitment to expediting the development and approval of drugs for patients with serious and life-threatening diseases.”