Secura Bio Announces Copiktra (duvelisib) Strategic Focus On T-cell Lymphoma And Voluntary U.S. Withdrawal Of The Relapsed Or Refractory Follicular Lymphoma Indication

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company dedicated to the worldwide development and commercialization of impactful oncology therapies, has voluntarily withdrawn the U.S. Copiktra indication for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.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.

After a Secura Bio strategic assessment of Copiktra and subsequent consultation with the U.S. Food and Drug Administration (FDA), the company made the determination that the current treatment landscape for FL patients in the U.S. and the logistics, cost and timing of the post-marketing requirements (PMR) for Copiktra in FL was no longer merited. Secura Bio has determined that a more prudent application of future effort and resource is in new applications for T-cell lymphoma where initial data appear encouraging. The company is looking forward to working with the FDA and gaining guidance regarding an appropriate regulatory and clinical plan.

This is a business decision and is not related to any changes in either the efficacy or safety associated with Copiktra. This decision impacts only the relapsed or refractory FL indication in the U.S. and does not affect other approved indications for Copiktra in the U.S. and other countries, including the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.

Secura Bio will work with the FDA over the coming weeks to complete the label revision process, including notification of U.S. healthcare professionals in a timely manner about the label change. Patients in the U.S. being treated with Copiktra for relapsed or refractory FL should discuss their care with their healthcare provider. Patients, or their healthcare providers, who have questions or concerns are encouraged to contact Secura Bio at (805) 479-7793 for assistance. Secura Bio patient support specialists can help answer questions, including insurance coverage and reimbursement options.

About Secura Bio, Inc.

Secura Bio is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies for physicians and their patients. For more information on Secura Bio, please visit www.securabio.com

SOURCE Secura Bio, Inc.