Secura Bio says it has no plans to change the marketing status of its PI3K inhibitor Copiktra (duvelisib), which won full approval in September 2018 as a third-line treatment for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Updated pivotal trial results raised fresh safety questions about that approval, and the FDA’s outside oncology experts last September voted 8-4 against the drug’s benefit-risk profile.

New York-based TG Therapeutics voluntarily withdrew its pending Biologics License Application (BLA) and supplemental New Drug Application (sNDA) for its combination of ublituximab and Ukoniq (umbralisib), dubbed U2, for adults with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

BeiGene’s Brukinsa is already approved in the small indication of mantle cell lymphoma. With a new trial win, the drug is on track to open up a much larger market.

Brukinsa outperformed the combination of bendamustine and rituximab at staving off cancer progression or death in newly diagnosed patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), BeiGene said Thursday.

Imbruvica, in combination with Roche's Gazyva, was approved as the first chemotherapy-free treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma.

A combination of AbbVie's blood cancer drugs Imbruvica and Venclexta has delivered high response rates early into a mid-stage study, called CAPTIVATE, of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).