Onyx Pharmaceuticals this afternoon issued an announcement summarizing its full year and fourth quarter 2011 financial results.

Company man­agement also discussed the firm's financial results and near-term plans in an analyst conference call later in the day.

Contrary to speculation by some analysts, today's announcement and man­agement discussion did not provide any significant new in­­for­ma­tion about the ongoing review by the U.S. Food and Drug Administration (FDA) of carfilzomib (Kyprolis).

Onyx (NASDAQ: ONXX) has submitted a new drug application to the FDA asking it to approve car­filz­o­mib as a new treat­ment for re­lapsed and refractory multiple myeloma.

The com­pany did con­firm today that it con­tinues to have discussions with the FDA about the car­filz­o­mib application.

In addi­tion, the com­pany reported that it has not yet been told by the FDA if or when the agency will schedule a meeting of its Oncologic Drugs Advisory Committee (ODAC) to advise the agency on car­filz­o­mib's new drug application.

The FDA typically requests an ODAC advisory meeting when the agency is reviewing a new oncology drug.  The agency is not legally bound to follow the advice of its advisory committees regarding new drug applications, but it usually does.

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

Then, as the latest car­filz­o­mib clinical trial results were being presented at the American Society of Hematology meeting in December (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, meaning that the FDA must make a decision about car­filz­o­mib by July 27.

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.

Similarly, given the July 27 deadline for an FDA decision regarding car­filz­o­mib, there had been speculation that Onyx today would announce a date for an ODAC review meeting.

During today's conference call, however, Onyx man­agement not only said that it does not know whether or when an ODAC meeting will take place.  It also said that it had no plans to im­medi­ately notify investors or patients should Onyx learn that the FDA has scheduled an ODAC review of car­filz­o­mib.

The com­pany's Chief Executive Officer, Dr. Anthony Coles, committed only to notifying the public "in a timely fashion" should Onyx learn that an ODAC review of car­filz­o­mib has been scheduled.  He explained that, upon learning such news, the com­pany would want first to focus all its energies on preparing for the ODAC meeting.

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 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.  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).

In other news from Onxy today, the com­pany said that it has completed enrollment of patients in a Phase 3 clinical trial of car­filz­o­mib.

The study is comparing car­filz­o­mib in com­bi­na­tion with Revlimid (lena­lido­mide) and dexamethasone (Decadron) versus Revlimid and dexa­meth­a­sone alone in patients with re­lapsed multiple myeloma. Interim results from the study could be available as soon as the first half of 2013.

Onyx today also discussed its plans for a head-to-head clinical trial that will directly compare the efficacy and safety of car­filz­o­mib versus Velcade in re­lapsed and refractory myeloma patients.  In addi­tion, the com­pany is considering whether to conduct a similar head-to-head trial in newly diagnosed patients.

Finally, Onyx said it is moving forward with plans to develop its second proteasome inhibitor, oprozomib (ONX0912).  Unlike car­filz­o­mib, which is an injectable drug, oprozomib can be admin­istered orally.

For more in­­for­ma­tion, see the Onyx press release about the com­pany’s earnings report and the completion of enrollment in the car­filz­o­mib Phase 3 trial.