Pharmacyclics Rockets on FDA Action - TheStreet

California biotechnology company

Pharmacyclics

(PCYC)

was burning up the premarket session after the Food and Drug Administration granted expedited review to its experimental brain cancer treatment, Xcytrin.

The drug is an injection that is supposed to treat cancer in the brain that has spread from another part of the body, in this case the lungs.

According to the company, the FDA based its decision on clinical trials that showed Xcytrin in combination with whole brain radiation therapy helped nonsmall cell lung cancer patients.

The shares were recently changing hands on Instinet for $8.75, up $2, or 34%, from their Monday close.

"Fast-track" designation means the FDA will facilitate and expedite the development and review of the application for the approval of a new drug. It's granted when the treatment is for a serious or life-threatening condition and demonstrates the "potential to address an unmet medical need."