Lonsurf (TAS-102) is an oral 2-drug combination pill that is intended for metastatic colorectal cancer patients who have failed on chemotherapy and biological therapy.
A combination pill to treat metastatic colorectal cancer (mCRC) patients who are refractory to other treatments has received the FDA’s endorsement. Developed by Princeton-based Taiho Oncology Inc, Lonsurf (TAS-102) is an oral 2-drug combination pill that includes trifluridine and tipiracil and is intended for mCRC patients who have failed on chemotherapy and biological therapy.
Excluding melanoma, CRC is the third most common cancer diagnosed in the United States and the third leading cause of cancer-related deaths in the United States. According to the National Cancer Institute, CRC will be responsible for about 8.4% of cancer-related deaths in 2015.
Today's approval was based on Taiho’s submission of results from its phase 3 RECOURSE trial, an international, randomized, double-blind, study that included nearly 800 participants from the United States, Japan, and the European Union. The results, presented this year at the annual meeting of the American Society of Clinical Oncology, found that overall survival (OS) improved in mCRC patients in the TAS-102 arm across all 3 geographical subgroups—patients treated with TAS-102 lived an average of about 2 months longer compared with those given the placebo. Overall, the incidence of adverse events (AEs), serious AEs, and hospitalizations was similar across the subpopulations treated with TAS-102.
Because of the drug’s myelosuppressive effect, the FDA has advised physicians to obtain a complete blood count on patients prior to each treatment cycle and to continue monitoring them during treatment.
“The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “But there are many patients who still need additional options, and today’s approval is a testament to the FDA’s commitment to work with companies to develop new drugs in disease areas where unmet needs remain.”
Reducing Time Sitting Can Help Lower BP in Older Adults, Randomized Trial Finds
April 20th 2024The randomized trial found that reducing sitting time over a 6-month period was association with reduced systolic blood pressure (BP) among a group of older patients with obesity and high rates of hypertension.
Read More
Early Involvement Critical in Treating Immunotherapy-Induced Overlap Syndrome
April 19th 2024A series of case studies reveals the importance of early diagnosis and involvement of special teams of clinicians when dealing with potential cases of overlap syndrome, which encompasses myocarditis, myasthenia gravis, and immune checkpoint inhibitor–related myositis.
Read More
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
Listen
Real-World Study Reveals Key Insights Into DLBCL Treatment Patterns, Outcomes
April 18th 2024A recent study offers valuable insights into the characteristics, treatment patterns, and outcomes of diffuse large B-cell lymphoma (DLBCL) in patients across different lines of therapy, providing a look into the landscape of DLBCL management.
Read More
Gene, Light Therapy Combo Shows Promise Against Prostate Cancer Cells in Proof-of-Concept Study
April 18th 2024In their preclinical model, the researchers found efficacy both in vitro and in vivo by using CRISPR-Cas9 to mimic porphyria and combining the technology with light therapy.
Read More