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FDA OKs Ixempra for advanced breast cancer
The U.S. Food and Drug Administration has approved Ixempra, a new anti-cancer treatment, for use in patients with metastatic or advanced breast cancer.
"This approval is important because it provides certain patients with a new chemotherapy option in instances where other drugs have failed," said Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research.
Ixempra (ixabepilone) was approved for use in combination with another cancer drug, capecitabine, in patients who no longer respond to two other chemotherapy treatments. The prior treatments included an anthracycline (such as doxorubicin or epirubicin) and a taxane (such as paclitaxel or docetaxel).
Ixempra, which is administered by intravenous infusion, was also approved for use alone in patients who no longer benefit from an anthracycline, a taxane and capecitabine.
The drug is distributed by the Bristol-Meyers Squibb Co. of Princeton, N.J.
Copyright 2007 by United Press International
Ixempra (ixabepilone) was approved for use in combination with another cancer drug, capecitabine, in patients who no longer respond to two other chemotherapy treatments. The prior treatments included an anthracycline (such as doxorubicin or epirubicin) and a taxane (such as paclitaxel or docetaxel).
Ixempra, which is administered by intravenous infusion, was also approved for use alone in patients who no longer benefit from an anthracycline, a taxane and capecitabine.
The drug is distributed by the Bristol-Meyers Squibb Co. of Princeton, N.J.
Copyright 2007 by United Press International
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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%u2019s 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).