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More About Delay Of The New Drug Application (NDA) Filing For Carfilzomib Thursday

Home/More About Delay Of The New Drug Application (NDA) Filing For Carfilzomib Thursday

More About Delay Of The New Drug Application (NDA) Filing For Carfilzomib Thursday

Yesterday I reported that Onyx Pharmaceuticals had temporarily delayed their drug application with the FDA for the new and highly anticipated anti-myeloma drug, carfilzomib.

In the article, I passed along an e-mail I received from the company’s Director of Corporate Communications & Investor Relations, Lori Murray.

I was able to reach Lori by phone later in the day.  She agreed to answer some additional questions about the delay.

Lori shared with me that, although everyone at Onyx was a bit disappointed, the delay should only set things back by about six months.  She confirmed it isn’t unusual for the FDA to request additional data before accepting new filings.  Lori added that company officials were already evaluating the possibility of filing an additional FDA application which, if accepted, would allow expanded access to carfilzomib in compassionate use cases until the drug is approved for use by relapsed multiple myeloma patients. 

That would be very good news!   I should know more in a month or so.
Feel good and keep smiling!  Pat