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ONO PHARMA Announces Enrollment is Complete for the First Arm of the PROSPECT Study of Tirabrutinib in U.S. Patients with Relapsed or Refractory PCNSL | ||
By: PR Newswire Association LLC. - 25 Mar 2024 | Back to overview list |
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Primary central nervous system lymphoma (PCNSL) is a rare and aggressive lymphoma with no approved treatment in the U.S.1 OSAKA, Japan, March 25, 2024 /PRNewswire/ -- ONO Pharmaceuticals, Co., Ltd. today announced it has completed target patient enrollment of the first arm (Part A) of the PROSPECT Study, a Phase 2 clinical trial evaluating the safety and efficacy of tirabrutinib (ONO-4059) in U.S. patients with relapsed or refractory primary central nervous system lymphoma (R/R PCNSL). "A PCNSL diagnosis can be frightening for patients, and treatment options approved by the FDA are critically needed in the U.S.," said Kiyoaki Idemitsu, Executive Officer / Executive Director, Clinical Development of ONO PHARMA. "Completing enrollment of the first arm of this U.S. study is an important step in bringing a therapeutic option to patients with R/R PCNSL in the U.S. We are very grateful to everyone involved with this clinical trial." The first arm (Part A) of the PROSPECT Study is evaluating the safety and efficacy of tirabrutinib in patients with R/R PCNSL who received previous treatment with high-dose methotrexate-based regimens. Enrollment is now complete for Part A. ONO PHARMA continues to enroll newly diagnosed and previously untreated PCNSL patients in the second arm of the study (Part B), evaluating tirabrutinib in combination with one of two high-dose methotrexate-based regimens as first-line therapy in the PROSPECT Study (theprospectstudy.com and clinicaltrials.gov). PCNSL is a rare and aggressive extranodal non-Hodgkin lymphoma with historically poor survival rates.1 PCNSL affects the brain, its protective membranes, the spinal cord, and/or eye, without systemic involvement at the time of diagnosis.1 In the U.S., the incidence of PCNSL is approximately five out of 1,000,000 people per year, with higher rates in people over 65 years old.2 Tirabrutinib is a highly selective irreversible Bruton's tyrosine kinase inhibitor discovered by ONO PHARMA in Japan. In March 2023, the U.S. Food and Drug Administration granted Orphan Drug Designation to tirabrutinib for the treatment of PCNSL.3 Tirabrutinib is currently approved for R/R PCNSL treatment in Japan, Taiwan, and South Korea.3 "This is an important milestone for ONO as it builds its clinical trial program in the U.S.," said Kunihiko Ito, President and CEO of ONO PHARMA USA. "For decades, ONO's commitment to innovation in oncology has helped change treatment paradigms for patients all over the world. We look forward to continuing this legacy as we investigate tirabrutinib for PCNSL in the U.S." About PCNSL About Tirabrutinib About the PROSPECT Study About ONO PHARMA USA References
View original content to download multimedia:https://www.prnewswire.com/news-releases/ono-pharma-announces-enrollment-is-complete-for-the-first-arm-of-the-prospect-study-of-tirabrutinib-in-us-patients-with-relapsed-or-refractory-pcnsl-302097972.html SOURCE Ono Pharmaceutical co., ltd. |
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