Shares of Spectrum Pharmaceuticals Inc., an Irvine drug developer, plunged more than 30% Friday after regulators raised the prospect of a delay in approving the company’s prostate cancer pill.
Food and Drug Administration reviewers said they plan to ask an oncology advisory panel if action on the drug’s application should be halted until final patient survival data is in from a clinical trial.
Spectrum shares were down more than 20% Friday with a market value of $135 million.
FDA reviewers raised five issues with an application for submitted by Spectrum partner GPC Biotech AG of Germany for satraplatin, which is also called Orplatna.
Regulators asked whether one of the main goals in a GPC study was an acceptable basis for approval and if pain measurements are reliable.
Outside oncology experts are set to consider the application on Tuesday for input on those issues and whether officials should defer a decision on the drug.
Spectrum, through a spokeswoman, declined comment.
For more on this story, see the July 23 edition of the Business Journal.
