RxTrials Institute Drug Pipeline Alert

Genta has entered a worldwide licensing agreement with Daiichi Sankyo for its oncology drug tesetaxel, which was placed on clinical hold by the FDA after severe neutropenia led to death in several patients with advanced cancer.

Genta said the FDA has provided “clear and specific guidance” on the tasks required to lift the hold. “We believe these tasks are straightforward, and we look forward to resuming key clinical trials,” the company said.

More than 250 patients worldwide have been treated with oral tesetaxel in Phase I and Phase II clinical trials, with the major side effect being low blood counts, particularly for white blood cells. However, the trials did not result in severe infusion reactions, which have been associated with other taxanes such as Bristol-Myers Squibb’s Taxol (paclitaxel) and sanofi-aventis’ Taxotere (doxetaxel), Genta said.

Under the agreement, Daiichi Sankyo will receive upfront payments, milestone payments and royalties.