SPPI.O
) said
U.S. regulators have extended the review date of its
experimental cancer drug, Zevalin, to July 2.
The decision by the U.S. Food and Drug Administration comes
after the regulator received a major amendment to the
Supplemental Biologics License Application for use of Zevalin
as a treatment for patients with indolent B-cell non-Hodgkin’s
lymphoma (NHL), the company said.
The drug has received priority review status from the FDA.
An estimated 30,000 people in the United States will be
diagnosed this year with indolent NHL, a slow-growing cancer of
the lymphatic system, according to the National Cancer
Institute.
The company also said it would acquire the 50 percent
interest it does not already own in RIT Oncology LLC, a joint
venture between the company and Cell Therapeutics Inc (
CTIC.O
)
to develop Zevalin, for $18 million.
Sales of Spectrum’s Fusilev, a drug approved to treat
osteosarcoma, a type of bone cancer, will help fund the
acquisition, Chief Executive Rajesh Shrotriya said.
Shares of Irvine, California-based Spectrum closed at $1.65
Friday on Nasdaq, while Cell Therapeutic shares closed at 5
cents.
(Reporting by Anand Basu in Bangalore; Editing by Pratish
Narayanan)