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FDA Sets Date For Carfilzomib Advisory Committee Meeting

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Published: Apr 26, 2012 10:31 am

Onyx Pharmaceuticals announced this morning that the U.S. Food and Drug Administration has set a date for an advisory committee meeting to review the company’s application for approval of carfilzomib.

Onyx (NASDAQ: ONXX) has applied to the Food and Drug Administration (FDA) to have carfilzomib (Kyprolis) approved for treatment of relapsed and refractory multiple myeloma patients who have had at least two prior therapies.

The Oncologic Drugs Advisory Committee (ODAC), which advises the FDA regarding the potential approval of new cancer drugs, will meet on June 20 to review the  carfilzomib application.

The FDA is not legally bound to follow the advice of its advisory committees regarding new drug applications, but it usually does.  The agency is required to make a decision about carfilzomib’s application by July 27.

Onyx completed the FDA submission of carfilzomib’s new drug application last September.

In December, as the latest carfilzomib clinical trial results were being presented at the American Society of Hematology meeting (see related Beacon news), Onyx announced that the FDA granted “standard review designation” to carfilzomib’s application, rather than “priority review” (see related Beacon news).

Under the FDA’s standard review process, the agency must decide whether to approve a drug within 10 months of the time the drug is submitted for review.

If the FDA had granted priority review to carfilzomib, the agency would have needed to complete its review within six months.  The FDA can grant priority review to drugs that offer significant advances in treatment, particularly for diseases in which there are inadequate treatment options.

Financial markets reacted negatively to the FDA’s decision to grant only a standard review, interpreting the decision as a sign the FDA has concerns about carfilzomib’s new drug application.

Onyx’s stock price dropped more than 10 percent in the days immediately prior to, and after, the announcement of the FDA standard review decision.

There also has been discussion among industry analysts that potential FDA concerns about carfilzomib might lead the agency to skip scheduling an advisory board meeting to review the drug.  Had that happened, the FDA would have been unlikely to approve the drug this year.

Thus, the announcement that there will be an ODAC review of carfilzomib in June will be seen by many as increasing the chance the FDA will approve the drug by the end of July.

If the FDA makes a positive decision regarding carfilzomib’s new drug application, Onyx will be allowed to start marketing the drug in the United States as a new treatment for relapsed and refractory myeloma.

A negative decision by the FDA would delay the launch of carfilzomib until Onyx is able to address any questions or concerns raised by the FDA.

Until carfilzomib receives FDA approval, the drug is available through Onyx’s expanded access program for relapsed and refractory myeloma patients in the U.S. who do not have any other treatment options.

Carfilzomib works similarly to the existing multiple myeloma treatment Velcade (bortezomib).  Both drugs are in the class of drugs known as proteasome inhibitors.  They work by preventing the breakdown of protein in cancer cells, triggering their death.

Along with pomalidomide – a chemical relative of multiple myeloma drugs Revlimid (lenalidomide) and thalidomide (Thalomid) – carfilzomib is considered one of the most promising new myeloma treatments that could be approved by the FDA in the next few years.

Celgene, the company developing pomalidomide, also announced this morning that the company completed the submission of its application to the FDA for the approval of pomalidomide for the treatment of relapsed and refractory myeloma (see related Beacon news).  Submission of a similar application to the European Medicines Agency is expected by the end of June.

If regulatory agencies give pomalidomide a favorable review, the drug could be available in the U.S. and Europe by late 2012 or early 2013 (see related Beacon news).

For more information regarding the carfilzomib FDA advisory meeting in June, see the Onyx press release.

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2 Comments »

  • suzierose said:

    Great News!!

    Thanks for the update.

  • Nancy Shamanna said:

    it is wonderful that two new drugs used to combat MM may soon be approved in the US. that would certainly give oncologists more options for their patients, and would hopefully start the ball rolling for approval in other countries too!