FDA Anticipates Spike in Oncology Drugs, Reduction in Shortages

Posted 05 June 2012 | By Alexander Gaffney, RAC 

Could 2012 be the year a long-running drought in product approvals and availability finally ends? The US Food and Drug Administration (FDA) is of the opinion that it might just be-if only for oncology products, at least.

Reuters reports Dr. Richard Pazdur, FDA's head of the Office of Hematology Oncology Products within the Center for Drug Evaluation and Research (CDER), told attendees of the American Society of Clinical Oncology (ASCO) conference in Chicago he anticipates FDA receiving upwards of 20 new drug applications for products intended to treat cancer in 2012.

FDA approved only ten oncology drugs in 2011-33% of all products approved by the agency.

Why the potential increase? Advances in scientific understanding, said Pazdur. "There is greater understanding of some of the disease processes," Pazdur explained.

The agency is also putting a greater emphasis on conditional approvals in which it can approve a drug for use in a restricted population based on a reduced number of clinical trials, with the sponsor to conduct the trials at a later date. If the sponsor is unwilling to conduct additional trials, or if the data shows the product is ineffective, the approval can be revoked.

But this doesn't mean just any drug will be given an expedited approval or conditional approval, said Pazdur. "Our staff is interested getting the drugs out earlier [but] it has to be a drug that we really think is important," he explained.

The agency is working to meet with drug developers on a consistently earlier basis to make sure up-and-coming products aren't bogged down under regulatory uncertainty, said Pazdur.

"When we are seeing drugs with a high degree of efficacy-so-called 'breakthrough' drugs-it requires a different interaction with the companies," Pazdur said. "We may change the registration strategy or the size of the trial" to speed up the company's path through FDA, added Pazdur.

Another piece of oncology news to come out of the ASCO meeting regarded drug shortages, which have had a pronounced impact on cancer drugs such as methotrexate and Doxil-both of which have been subject to dramatic actions by FDA to ease shortages.

In comments to The Wall Street Journal, Richard Schilsky, head of government relations for ASCO, said the shortage of cancer drugs is beginning to ease. "The good news is the frequency of drug shortages has begun to decline," said Schilsky.

Despite the progress, the director of FDA's drug shortage program, Dr. Sandra Kweder, said the agency is still "extremely concerned about the shortages."

"We're not out of the woods yet, by any measure," added ASCO President Michael Link.

Read more:

Reuters - U.S. on track to approve more cancer drugs in 2012

WSJ - Cancer Doctors Say Some, Not All, Drug Shortages Have Eased

Med Page Today - ASCO: Drug Shortages Force Change in Cancer Treatment

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