ODAC Meeting Could Hold Surprises
See what procrastination will get you?
As I've noted before, the FDA can offer a drug full or accelerated approval. Accelerated approval (also called "Subpart H" approval) was originally created to get HIV/AIDS drugs to market faster. The burden of proof of efficacy is de facto lessened and the size and number of trials necessary to achieve approval are also reduced. In exchange for this, drug developers must agree to run confirmatory studies post-approval to convert the accelerated approval into a full approval. If the confirmatory studies are negative, the legislation authorizing accelerated approval implies the FDA has the power to remove the drug from the market.
I should note the FDA is unsure whether they can remove a drug from the market unilaterally under the accelerated approval guidelines. The legislative intent is clear, but since it does not say it explicitly in the text of the law the FDA dances around the issue.
The FDA finessed this issue with Iressa. According to the FDA's Oncology Division, Iressa did not work as advertised in the confirmatory trials. Because Division head Dr. Richard Pazdur didn't want to approve the drug in the first place, he was particularly motivated to get it off the market. He pressured Astra-Zeneca (AZN) into agreeing to a label change that effectively removed the drug from the market except for people who were already taking it.
At the November 8 meeting, ODAC is scheduled to review confirmatory trial commitments from a host of companies: Johnson & Johnson's (JNJ) Doxil, MedImmune's (MEDI) Ethyol, Ligands' (LGND) Ontak, SkyePharma's (SKYE) DepoCyt, Pfizer's (PFE) Celebrex (oncology application only), Wyeth's (WYE) Mylotarg and Genzyme's (GENZ) Campath. Most of these drugs were reviewed back in 2003, the last time ODAC took up this question.
J&J's commitment for Doxil (liposomal doxorubicin) in Kaposi's sarcoma is listed by FDA as having been submitted.
Since the current ODAC panel has been especially concerned with post-marketing commitments, I would expect companies with unfulfilled post-approval commitments to be at risk for ODAC recommending their drugs be removed from the market. As I noted above, whether the FDA will follow this recommendation is another matter given their reading of the law. I would expect such a decision out of ODAC would convince the FDA to ask Congress to clarify their powers in this regard.
The following have ongoing, but incomplete commitments:
• MedImmune for Ethyol (amifostine) in cisplatin toxicity prevention
• Ligand for Ontak (denileukin diftitox) in cutaneous T-cell lymphoma
• Pfizer for Celebrex (celecoxib) in adenomatous polyps
• Wyeth for Mylotarg (gemituzumab) in acute myeloid leukemia
• Genzyme for Campath (alemtuzumab) in chronic lymphocytic leukemia
• AstraZeneca for Iressa in lung cancer
• ImClone (IMCL) for Erbitux in colorectal cancer
• GlaxoSmithKline (GSK) for Bexxar in NHL
• Eli Lily (LLY) for Alimta in non-small cell lung cancer (NSCLC)
• Novartis (NVS) for Gleevec in GIST (CML has already been converted to full approval)
The following have no trials ongoing to satisfy their commitment and are, therefore, in the most danger for having their drugs pulled.
• SkyePharma's for DepoCyt (liposomal cytarabine) in neoplastic and lymphomatous meningitis (incomplete due to prior manufacturing problems)
• AstraZeneca's Arimidex for breast cancer in the adjuvant setting
• Genzyme for Clolar in pediatric acute lymphoblastic leukemia (ALL)
• BiogenIdec (BIIB) for Zevalin in NHL (started, but not currently enrolling patients)
Not all of the companies in the two sets of bullet points are up for discussion, but it is safe to say all will be affected by the decision. While I'm not expecting mayhem and destruction out of this ODAC panel meeting (mostly due to the FDA's conservative interpretation of the Subpart H law), anyone holding those companies should factor into their risk/reward profile an ODAC panel that vociferously objects to delays in post-marketing commitment studies and perhaps even recommends the FDA pull one or more of these drugs from the market.
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