WHIPPANY, N.J: Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies.
“With this milestone, we are one step closer to making copanlisib available in the U.S. to the community of doctors and patients facing a very difficult-to-treat disease,” said Carsten Brunn, Head of Bayer Pharmaceuticals, Americas Region. “We look forward to continuing to work with the FDA throughout the review process.”
The FDA grants Priority Review for the applications of medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months (compared to 10 months under standard review).
The regulatory submission for copanlisib is based on data from the Phase II open-label, single-arm CHRONOS-1 study evaluating patients with relapsed or refractory indolent non-Hodgkin’s lymphoma (iNHL). The full analysis set comprised 142 patients, of which 141 patients had iNHL. The full data set was presented at the American Association for Cancer Research (AACR) Annual Meeting 2017. Data from the FL subset of the CHRONOS-1 trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 in June.
Bayer is seeking Accelerated Approval of copanlisib for FL under FDA regulations 21 CFR Part 314 Subpart H. The compound was also granted Fast Track and Orphan Drug Designation by the FDA in this indication.
CHRONOS-1 is an open-label, single-arm Phase II study (ClinicalTrials.gov Identifier: NCT01660451) evaluating copanlisib as a monotherapy in non-Hodgkin’s lymphoma patients. CHRONOS-1 was designed to evaluate the efficacy and safety of copanlisib in patients with relapsed or refractory indolent NHL, including follicular lymphoma (FL), who received at least two prior therapies. The primary endpoint of CHRONOS-1 is the objective tumor response rate, with duration of response, overall survival, progression-free survival, quality of life, and safety serving as secondary endpoints.
Non-Hodgkin’s Lymphoma (NHL) is a cancer that starts in cells called lymphocytes, which are part of the body’s immune system.1 It is the seventh most common cancer in the U.S.2 Estimates are that nearly 73,000 new cases of NHL will be diagnosed in 2017, including both children and adults.3 It accounts for more than 20,000 deaths per year.3 NHL comprises a heterogeneous group of malignancies with differing patterns of behavior and responses to treatment.4 NHL can be divided into two prognostic groups: the indolent lymphomas and the aggressive lymphomas.4 About 1 out of 5 lymphomas in the U.S. is follicular lymphoma.5 The term follicular means that the cells tend to grow in a circular pattern in lymph nodes.5
Copanlisib is a pan-Class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms, being developed by Bayer.
The efficacy and safety of copanlisib has not been established. The broad clinical development program for copanlisib also includes Phase III studies in indolent non-Hodgkin’s lymphoma (NHL) patients who have relapsed or are refractory to prior therapies.