Ixempra, a new chemotherapy drug from Bristol-Myers Squibb (NYSE:BMY), has been approved for sale by the U.S. Federal Drug Administration and is expected to be available for sale within the next few days.
Ixempra, a new class of drugs called epothilones, is a stand alone treatment for 
women with advanced breast cancer that has not responded to other anthracyclines or taxanes.
"We now have an important new option for patients with metastatic breast cancer who have rapidly progressed through currently approved chemotherapies," Dr. Linda Vahdat, a cancer expert at New York-Presbyterian Hospital/Weill Cornell Medical Center, said in a Bristol-Myers statement.
Patients who took Ixempra with Xeloda, in clinical trials, had tumors that either shrank or did not grow for an average of 1.6 months longer than those that took only Xeloda. However, patients with a history of moderate to severe liver failure should not take the combination due to the increased risk of toxicity and death.
It is estimated that 160,000 women, and some men, are diagnosed with breast cancer each year and about 40,000 despite current available treatments.
As the good people over at the WSJ Health Blog tell us, at a time when "targeted" cancer treatments like Herceptin and Gleevec are all the rage, chemotherapy can seem like a retro blunderbuss. The FDA's approval of a Bristol-Myers Squibb drug harkens back to the old-school for breast cancer patients who aren’t responding to other treatments.
Ixempra would be the first in a new class of chemotherapy drugs called epothilones. The medicine, which is injected, works by inhibiting tubulin, a protein that acts like a scaffold inside cancer cells and is necessary for their proliferation. Known generically as ixabepilone, the drug tries to stymie tumors by keeping cancer cells from replicating successfully. Ixempra would be used alone or in combination with Xeloda, in patients who have failed two or three other chemo drugs.
For use by women who have tried - without success - prior types of treatment? Why not give them the "right" drug or combinations the "first" time around? Why not have a bio-marker to aid the physician in selecting an effective agent or combination of agents the first time around, to avoid exposing the patient to ineffective harmful drugs, reducing the cost and decreased quality of life associated with ineffective treatment? Everyone would agree that the earlier in the course of the disease that the most active treatment is given, the better the result for the patient.
The downside of Ixempra is that chemo that goes after dividing cells, also attacks healthy cells along with cancerous ones. Ixempra’s side effects include fatigue, hair loss and anorexia. Patients may experience a decrease in red blood cells, muscle pain, joint pain, the feeling of pins and needles in their fingers and toes, and in severe cases, inability to use their hands and feet fully. Does Taxol sound familiar?
Scores of "new" cancer drug applications are for me-too drugs which might show only miniscule clinical improvement in trials, yet they somehow gain approval. So, for 1.6 months longer, patients can suffer from one or all of the above and still end up dead. Since they are marketed as if they were important new breakthroughs, they have very high prices. For most patients the total cost of a full course of Ixempra is expected to run from $18,440 to $23,050. Does that sound familiar, too?
Posted by: gpawelski | October 18, 2007 6:11 PM | Permalink to Comment