SUMMERLIN, Nev., Dec. 7, 2023 /PRNewswire/ -- Secura Bio, Inc. (Secura Bio) - (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announces that it has added two members to the board of directors of Secura Bio Holdings, Inc. The new members are Joerg Moeller, MD and Charles (Chip) R. Romp.
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.
SUMMERLIN, Nev., Jan. 9, 2023 /PRNewswire/ -- Secura Bio, Inc. (Secura Bio) - (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announces that the European Commission (EC) issued an Orphan Drug Designation for duvelisib for the treatment of patients with peripheral T-cell lymphoma (PTCL). Duvelisib was previously granted orphan drug designation by the United States Food and Drug Administration.
The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.
Safety red flags have previously drawn the FDA’s attention to accelerated approvals given to a group of blood cancer drugs called PI3K inhibitors. But, through an upcoming expert panel discussion, the FDA is poised to get tough on a PI3K inhibitor that's marketed under a full approval.
Secura Bio’s PI3K inhibitor Copiktra and Oncopeptides’ first-in-class blood cancer therapy Pepaxto are the latest two drugs that will be scrutinized at an upcoming FDA advisory committee meeting, as the drugmakers haven’t pulled indications off the market despite red flags from clinical trials.
The FDA sent a fresh warning on Thursday about Secura Bio’s embattled PI3K inhibitor Copiktra (duvelisib), which may increase the risk of death and severe side effects for patients as a third-line treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
SUMMERLIN, Nev., Dec. 14, 2021 /PRNewswire/ -- Secura Bio, Inc. (Secura Bio) - (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announced that new data for the treatment of relapsed or refractory(r/r) PTCL patients with COPIKTRA were presented at the 63rd annual meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.
SUMMERLIN, Nev., Dec. 3, 2021 /PRNewswire/ -- Secura Bio, Inc. (Secura Bio) - (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, has voluntarily withdrawn the U.S. COPIKTRA indication for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The relapsed or refractory FL indication received accelerated approval in September 2018 with the requirement that an additional confirmatory trial be conducted in order for the product to be granted full approval.
SUMMERLIN, Nev., Dec. 3, 2021 /PRNewswire/ -- Secura Bio, Inc. (Secura Bio) - (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, has voluntarily withdrawn the U.S. COPIKTRA indication for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. The relapsed or refractory FL indication received accelerated approval in September 2018 with the requirement that an additional confirmatory trial be conducted in order for the product to be granted full approval.