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.
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.
The FDA on Thursday warned about the possible increased risk of death or serious side effects with duvelisib (Copiktra) in adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
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company dedicated to the worldwide development and commercialization of impactful oncology therapies, has voluntarily withdrawn the U.S. COPIKTRA indication for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.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.
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 on May 19, 2021 the European Medicines Agency granted marketing authorization for COPIKTRA as monotherapy for the treatment of relapsed or refractory Chronic Lymphocytic Leukemia (CLL) in patients, who have received at least two prior therapies and for the treatment of Follicular Lymphoma (FL) that is refractory to at least two prior systemic therapies.
SUMMERLIN, Nev., April 8, 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 it has completed enrollment, with 101 patients, into the PRIMO study, which is evaluating COPIKTRA for the treatment of patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL). The completion of study enrollment is an important milestone in the continued development of COPIKTRA to treat T-cell lymphomas, a disease category for which it is not currently indicated.
SUMMERLIN, Nev., April 1, 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, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of COPIKTRA as monotherapy for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies and follicular lymphoma (FL) that is refractory to at least two prior systemic therapies.