Drug Development

TG Therapeutics maps a shortcut to the FDA with lead drug for CLL

TG Therapeutics $TGTX will take a shot at shortening the Phase III runway for its lead effort on ublituximab (TG-1101).

The biotech, which has been grappling with enrollment issues, says it plans to lop off the second stage of what was once a two-step development approach, dropping a look at progression-free survival with the FDA’s blessing and hustling overall response rate data to regulators if it bags positive results in the first half of 2017.

The drug is now in a Phase III in combination with ibrutinib compared with ibrutinib alone for chronic lymphocytic leukemia. And by dropping stage two, the biotech says it can save $10 million for its other pipeline projects.

But the prospect of changing the trial protocol at this late stage wasn’t greeted with universal acclamation. Some of the Twitter feedback included caution about the greater risks involved. And after a quick, sharp rise, the stock quickly dropped to 14% in the red.

TG CEO Michael Weiss had this to say:

“Given the Genuine enrollment challenges we’ve faced to date, we are very excited to accelerate the trial to a rapid conclusion, while also maintaining the ability to potentially file the data for accelerated approval. The Genuine study, as amended, remains a robust, randomized clinical trial, which we believe, if positive, could support accelerated approval for patients with relapsed/refractory high-risk CLL. Moreover, we believe the amended study and revised regulatory strategy is consistent with the recent accelerated approvals for novel agents in CLL, which notably were not pursuant to an SPA but occurred after the finding of positive ORR results. Importantly, with completion of enrollment now expected by year end, we and our clinical trial sites can focus our resources on completing our UNITY-CLL Phase 3 trial as quickly as possible.”

Their lead drug is also being studied for multiple sclerosis.

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Sr. Manager, Regulatory Affairs, CMC
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