(AP) — Spectrum Pharmaceuticals Inc. has won U.S. regulatory approval to market
a drug for treating patients with advanced colorectal cancer, an expanded use
for the injectable medication.
The Food and Drug Administration on Friday approved Fusilev
for use in those patients in combination with another medication called
5-fluorouracil, Spectrum said.
The expanded indication supplements the original FDA
approval of Fusilev in 2008. That approval involved treating the side effects
of the chemotherapy drug methotrexate in patients with osteosarcoma, a rare
type of bone cancer.
In October 2009, the FDA declined to approve Fusilev as a
treatment for colorectal cancer — a more common type of cancer than
osteosarcoma — saying the drug was not effective enough. Spectrum subsequently
submitted new data to the FDA, leading to Friday’s action.
Rajesh Shrotriya, CEO, chairman and president of Spectrum,
said the expanded approval “could represent a significant growth
catalyst” for his Irvine, Calif.-based company.
In the U.S.,
more than 90 percent of Fusilev’s clinical use is for the treatment of patients
with colorectal cancer, Shrotriya said.
The expanded approval means the drug can now be broadly
marketed. Fusilev has been available under various trade names in Europe and Japan,
primarily by Wyeth, Sanofi-Aventis and Takeda Pharmaceuticals, Shrotriya said.
Sales outside the U.S.
are estimated at more than $180 million a year, he said.
Spectrum announced the FDA approval after its shares fell
$1.36, or about 13 percent, to close at $9.00. The stock has risen 74 percent
over the past 12 months.
Spectrum plans to report first-quarter results after the
markets close Tuesday. On Wednesday, the company said its product sales surged
to around $40 million in the first quarter, almost six times its total from a