WHIPPANY, N.J., May 17, 2017 /PRNewswire/ -- Bayer announced today 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.

About CHRONOS-1
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.

About Non-Hodgkin's Lymphoma
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

About Copanlisib
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. Information about these trials can be found at www.clinicaltrials.gov and www.chronostrials.com.

The U.S. Food and Drug Administration (FDA) granted Priority Review designation for the New Drug Application (NDA) in May 2017 for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies. Copanlisib has also been granted Orphan Drug Designation for the treatment of splenic, nodal, and extranodal subtypes of marginal zone lymphoma. The compound is not approved by the FDA, the European Medicines Agency or any other health authority.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes three marketed products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2016, the Group employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.us.

© 2017 Bayer
Bayer^® and the Bayer Cross are registered trademarks of Bayer.

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

¹American Cancer Society. What is Non-Hodgkins Lymphoma? https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html. Accessed May 2017. 
²National Cancer Institute, SEER Stat Fact Sheets: Non-Hodgkin Lymphoma. https://seer.cancer.gov/statfacts/html/nhl.html. Accessed May 2017. 
³American Cancer Society. 2017 Cancer Facts & Figures. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf. Accessed May 2017. 
⁴ National Cancer Institute. Adult Non-Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version. https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq. Accessed May 2017. 
⁵American Cancer Society.Types of Non-Hodgkin Lymphoma. https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/types-of-non-hodgkin-lymphoma.html. Accessed May 2017.

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