Genentech Inc. and Biogen Idec Inc.
announced that their drug Rituxan combined with chemotherapy did well in
patients with chronic lymphatic leukemia. The combined treatment met its goal
of improving the survival rate in patients diagnosed with relapsed Chronic
Lymphocytic Leukemia, or CLL, with no progression of the disease.
Rituxan was first approved in 1997 to treat
non-Hodgkin’s lymphoma. Later it was approved for other uses, including against
rheumatoid arthritis in 2006. Rituxan, known generically as rituximab, had
sales last year of $2.3 billion in the U.S. alone, compared to $2.07
billion in 2006.
The study dubbed REACH is the second study
evaluating the combined treatment of Rituxan plus chemotherapy in treating CLL,
the most common adult leukaemia. REACH is a randomized study of 552 patients with
previously treated CD20-positive CLL, who were randomized to receive either a
combined treatment of Rituxan and chemotherapy, or chemotherapy alone.
The study showed the drug, combined with
fludarabine and cyclophosphamide chemotherapy, improved patient survival
compared with chemotherapy alone. The trial data is now under independent
review, the companies said, “for U.S. regulatory purposes.”
Earlier this year, another late-stage study
found that a similar Rituxan combo improved progression-free survival in
patients with CLL who had not previously received treatment.
The drug is already approved by the FDA for
the following indications: relapsed or refractory, low-grade or follicular,
CD20-positive, B-cell NHL as a single agent; previously untreated follicular,
CD20-positive, B-cell NHL in combination with CVP chemotherapy; non-progressing
(including stable disease), low-grade, CD20-positive B-cell NHL, as a single
agent, after first-line CVP chemotherapy; previously untreated diffuse large
B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based
chemotherapy regimens.
Lymphotic leukemia, the most frequent type
of leukaemia in adults, will affect 15,000 people in 2008, according to the
American Cancer Society.
In September, a fatal case of progressive
multifocal leukoencephalopathy, or PML, in a patient treated with arthritis
drug Rituxan has prompted pharmaceutical company Genentech to revise the
labeling of the drug. It was the first case when PML occurred in a patient
taking the drug for arthritis. The woman developed the infection more than a
year and a half after discontinuing treatment with Rituxan, the US Food and
Drug Administration said. Genetech said the risk of PML, a virus infection that
usually occurs in patients with impaired-mediated immunity, is already
mentioned on Rituxan’s label.
Genentech, based in California and Biogen, based in
Massachussetts are developing separate large-stage clinical trials testing
Rituxan as a treatment for lupus nephritis, an inflammation of the kidneys. Previous
studies have showed that the drug performed no better than a placebo against lupus
erythematosus, commonly called lupus.
On Monday, Genetech Inc announced the results
of a Phase III study investigating the addition of Avastin to Tarceva compared
with Tarceva alone for the treatment of patients with advanced non-small cell
lung cancer. The results were discouraging, as the combined treatment didn’t
prolong the lives of patients with advanced lung cancer.