Ridentem dicere verum quid vetat?
-Horace
Here's some hilarious "news" from the FDA, just hot off the press:
Taxotere Gets FDA Approval For Advanced Head And Neck Cancer Before Chemoradiotherapy And Surgery
Heh heh...
The US Food and Drug Administration (FDA) has approved Taxotere Injection Concentrate combined with cisplatin and 5-fluorouracil for induction therapy of locally advanced squamous cell carcinoma of the head and neck before chemoradiotherapy and surgery.
Ha ha ha ha ha!
Clinical investigator, Marshall Posner, MD, Medical Director of the Head and Neck Oncology Program at Dana-Farber Cancer Institute in Boston, said "The TAX 324 trial found that the addition of Taxotere to standard induction chemotherapy significantly improved patient survival, adding years to patients' lives. The approval of Taxotere to be given in combination with other standard chemotherapy as the first step in a therapeutic sequence followed by chemoradiotherapy and surgery is a significant advancement in treatment for patients with locally advanced head and neck cancer."
[Rolling on ground] Stop it! You're killing me! Hardeharahar!
Hey, why am I laughing, anyway?
I find this amusing because like countless other medical oncologists I've been using Taxotere for the treatment of head and neck cancer for years; in fact I'm going to see one of my patients in the office this week who has been cured with combined-modality treatment (i.e., chemotherapy, surgery and radiation therapy).
FDA approval is important, but in my practice it is used as a last resort to prevent insurance companies from denying payment of a particular anti-cancer treatment. We often submit high-quality medical evidence to support the usage of a new agent well before FDA approval is nigh. The hard work proving that Taxotere, or any other promising new drug, is safe and effective is completed long before the FDA descends from Mount Olympus to place it under the aegis of the federal government.
Thus, the humor in today's announcement sanctioning a chemotherapy drug that has been used for years to help save the lives of head and neck cancer patients. [Editor's note: he just wrote a sentence fragment. Not a surprise. Lack of formal education, you know.]
Good thing we didn't wait for the FDA to make up it's mind. What's that? I'm sorry, te audire non possum. Musa sapientum fixa est in aure.
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I understand the thrust of your argument. Still, it bothers me that such a small percentage of patients with advanced H/N cancer are entered into clinical trials. It seems that at the first whiff that a drug might have some effect, patients are offered off-protocol treatment with the 'new' cocktail. Some treatment regimens will eventually be proven effective in prolonging DFS; most, of course, will have no impact. Almost all are extraordinarily expensive.
What should be the role of the academic and non-academic medical oncologist in making certain that as many patients as possible are entered into NCI-approved clinical trials?
Nullum Gratuitum Prandium.
Submit to whom? Not the FDA, I'm guessing.
The only way FDA can formally approve a new use for a previously approved drug is if the NDA holder (in this case, Sanofi-Aventis) submits data and requests approval for the new use. All that really means is that the drug label (aka the package insert) is modified to add the new indication, alongside the previously approved one(s). Also, S-A drug reps will now be allowed to promote use of taxotere for this indication. (Only labeled indications can be promoted by the drug co., even if the drug is widely known to be safe & effective for other indications.)
I realize you guys frequently do the practical work to figure out how previously approved oncology drugs might by used in new indications. But unless/until that data is submitted for FDA review, they can't approve the new use.
qetzal is quite right. I wonder if there is any mechanism by which the medical community can go back to a drug maker and suggest new trials for adding the indication to the label. I would worry about taking a drug without a large trial to back up any new use.
Dear Cheerful Oncologist,
Unfortunately, despite the use of docetaxel induction chemotherapy, standard of care remains concurrent cisplatin-radiation, whether one likes it or not.
The Posner trial was unfortunately timed in choosing to compare 2 arms of induction chemotherapy, both of which are still considered not standard of care. In 91-11, induction was distinctly inferior to concurrent treatment.
I believe the trial comparing induction -> cisplatin-RT versus cisplatin-RT is underway.
very nice
Thanks.