Shares of Irvine-based Spectrum Pharmaceuticals Inc. plunged more than 20% in afterhours trading on Tuesday after a Food and Drug Administration panel recommended that the agency get more data before deciding whether to approve the company’s prostate cancer pill.
An FDA oncology advisory panel voted 12-0 to recommend that the agency, which usually follows its panel recommendations, wait for final clinical trial survival data before deciding whether to approve satraplatin, which likely would be sold under the name of Orplatna.
Spectrum is working with Germany’s GPC Biotech AG on satraplatin.
Spectrum shares fell 21% in afterhours trading on Tuesday. The company counted a recent market value of $120 million.
During the meeting, GPC officials said it could be another year for final survival results to be ready.
Spectrum and GPC are seeking regulatory clearance to sell the drug for advanced prostate cancer patients who don’t respond to hormone treatments or traditional chemotherapy.
Spectrum’s shares fell Monday after analyst Jonathan Aschoff of Brean, Murray, Carret & Co. downgraded the drug developer, citing FDA documents that introduced unexpected concerns about satraplatin.
“Although these documents tend to be negative, we believe that this document is particularly so,” Aschoff said in a research note.
Most doctors would probably not prescribe satraplatin if it’s approved without positive survival data, he said.
