TG Therapeutics' leukemia drug clears hurdle in key study

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[March 06, 2017] (Reuters) - TG Therapeutics Inc said on Monday a combination of its experimental cancer drug ublituximab and AbbVie Inc's Imbruvica outperformed Imbruvica alone in high-risk patients with a common form of leukemia.

TG's shares shot up 63.5 percent to $8.75 in premarket trading.

The late-stage study involved adult patients with high-risk chronic lymphocytic leukemia, who had undergone at least one prior therapy.

The study was designed to show that adding ublituximab would induce a statistically significant improvement in overall response rate by at least 20 percent between the two trial arms.

The absolute difference between the two groups of patients was about 30 percent, the company said.

TG said it would meet with the U.S. Food and Drug Administration to chart a path toward accelerated approval.

In 2015, AbbVie forked out $21 billion for Pharmacyclics, giving it joint ownership of the blockbuster leukemia treatment, Imbruvica, with Johnson & Johnson.

(Reporting by Natalie Grover in Bengaluru; Editing by Martina D'Couto)
 

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