Ixempra: New Metastatic Breast Cancer Treatment Approved by the FDA
October 23, 2007 by Gloria Gamat
Filed under Diseases & Conditions
Cancer is said to be metastatic once cancer in one body spreads to other body parts. In lay man’s term, the spreading of cancer to other locations.
When cancer becomes metastatic, it becomes an advanced stage cancer that is most often difficult to treat because the cancer becomes unresponsive to typical treatment.
Like metastatic breast cancer that becomes unresponsive to two chemotherapy treatments that include an anthracycline (such as doxorubicin or epirubicin) and a taxane (such as paclitaxel or docetaxel).
This is where new anti-cancer treatment Ixempra comes in that is recently approved by the FDA.
The approval of Ixempra includes the following:
- for use in combination with another cancer drug (capecitabine) in patients who no longer benefit from two other chemotherapy treatments: including an anthracycline (such as doxorubicin or epirubicin) and a taxane (such as paclitaxel or docetaxel
- for use alone in patients who no longer benefit from an anthracycline, a taxane and capecitabine
According to Douglas C. Throckmorton, M.D., deputy director of the FDA’s Center for Drug Evaluation and Research:
“This approval is important because it provides certain patients with a new chemotherapy option in instances where other drugs have failed.
FDA is working every day to support the development of safe and effective new therapies that benefit patients in need.”
Ixempra, a product of Bristol-Myers Squibb (BMS) is administered by intravenous infusion.
Find more details from the FDA News and the BMS press release.
As we enter the era of “personalized” medicine, it is time to take a fresh look at how we evaluate treatments for cancer patients. More emphasis should be put on matching treatment to the patient. Patients would certainly have a better chance of success had their cancer been chemo-sensitive rather than chemo-resistant, where it is more apparent that chemotherapy improves the survival of patient, and where identifying the most effective chemotherapy would be more likely to improve survival.
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.
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. 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 Abraxane sound familiar?
There have been truly minuscule improvements as a result of adjuvant chemotherapy and the net benefit to the community of breast cancer patients in the real world isn’t all that clear. And the criticism remains: All of the clinical trials resources have gone toward driving a square peg (one size fits all chemotherapy) into a round hole (notoriously heterogeneous disease).
In academic centers, the patients are entered into clinical trials of square peg in round hole therapy. In the private sector, patients are treated with drugs which generate the most revenue for the treating oncologists, overtreat with infusion chemotherapy, and encourage the patient to receive 2nd, 3rd, and 4th line chemotherapy, regardless of the likelihood of meaningful benefit.
After 4 infusions of Ixempra, I can no longer feel my feet, and my hands are a close second. Neuropathy does nothing. Sharp pains in the feet and toes and calves. This chemo should be taken off the market…..the price is TOO high. A tumor does not make a whole person.