Duvelisib, also known as IPI-145, was discovered by Intellikine, a company founded in September 2007 based on biochemistry research from the lab of
Kevan Shokat at the
University of California San Francisco. In mid-June 2016, Infinity announced results of Phase II clinical trial of duvelisib. In November 2016, Infinity exclusively licensed the worldwide rights to duvelisib to Verastem Oncology for little money compared to earlier deals; the deal included no upfront payment, a $6 million milestone for success in a Phase 3 trial in chronic lymphocytic leukemia, a $22 million payment for an FDA approval, and royalties. Duvelisib received
orphan drug designation in the United States for the treatment of peripheral
T-cell lymphoma (PTCL) in 2019, the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma in 2013, and the treatment of follicular lymphoma in 2013. In September 2020, duvelisib was sold by Verastem to Secura Bio, Inc. for $70 million and additional payments based on milestones and royalties. The US
Food and Drug Administration (FDA) required the drug manufacturer, Secura Bio, to submit the final 5-year survival results from the clinical trial, called DUO trial, a phase III, randomized, open-label trial. It was conducted in 319 participants with CLL or SLL who received a previous therapy that did not work or stopped working. These final results showed a possible increased risk of death with duvelisib compared to the monoclonal antibody ofatumumab. The rate of serious side effects, dose modifications, and deaths resulting from these side effects were also higher among participants who received duvelisib. The serious side effects included infections, diarrhea, inflammation of the intestine and lungs, skin reactions, and elevated liver enzyme levels in the blood. These safety findings were similar for other medicines in the same PI3 kinase inhibitor class. == Society and culture ==