FDA to Speed Review of Pharmacyclics Drug

Pharmacyclics Inc., which is developing heart and cancer drugs, said Tuesday that federal regulators agreed to speed a review of its experimental brain cancer medicine. Company shares surged as much as 42% on the midday news.

The Food and Drug Administration granted Xcytrin a so-called fast-track review for treating patients with lung cancer that has spread to the brain, the Sunnyvale, Calif.-based company said.

Pharmacyclics, which hasn’t filed an application for FDA approval yet, is conducting trials comparing patients treated with radiation plus its drug with those who receive only radiation.

Earlier trials suggested Xcytrin slowed the spread of cancer to the brain, it said.

“If they get approval for this drug, that’s fantastic for this company,” said David Bouchey, an analyst at CE Unterberg Towbin, who has a “short-term market perform” rating on the stock.

Xcytrin “could be worth a couple hundred million dollars within a year or two after launch.”

Shares of Pharmacyclics rose $1.62, a 25% gain, to $8.17 in Nasdaq trading, after earlier touching $9.28. They have more than doubled this year.

“Of cancer-related complications, none is more devastating than the development of brain metastases, which occurs early and frequently in lung cancer patients, the target patient population,” Chief Executive Richard Miller said.