KODE PPC ANDA
GlaxoSmithKline said on Tuesday that U.S. health regulators granted a priority review to a capsule form of its drug Hycamtin for the treatment of relapsed small cell lung cancer.
With priority review status, the U.S. Food and Drug Administration will make its decision on whether to approve the drug within six months, rather than the usual 10 month to 12 month review period.
The agency grants priority review to products that are considered to be potentially significant therapeutic advancements over existing therapies.
Hycamtin in its current intravenous formulation requires five consecutive days of therapy every three weeks. Oral Hycamtin, if approved, will allow patients to be treated at home, Glaxo said.