FDA approves Taiho Oncology’s Lonsurf
SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced the approval of Taiho Oncology’s Lonsurf (trifluridine and tipiracil). The pill, a combination of two drugs, is intended to treat metastatic colorectal cancer that has stopped responding to other therapies.
“The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease,” said Dr. Richard Pazdur, 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.”
Lonsurf marks the first FDA approval for Taiho Oncology.
“Patients with metastatic colorectal cancer, whose disease has progressed after treatment with standard therapies, have had limited therapeutic options to treat their disease,” Taiho president and CEO Eric Benn said. “Lonsurf helps address this unmet medical need by providing patients with a new therapeutic option that can help extend their overall survival.”
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- Availability of postage-paid Environmental Return System envelopes at all of its pharmacies with which customers can send their unwanted medications for secure and environmentally-safe disposal;
- Identification of physicians who exhibit extreme patterns of prescribing high risk drugs such as pain medications and suspension of dispensing their controlled substance prescriptions; and
- Advocating at the federal and state levels to implement policy changes to curb prescription drug abuse, such as mandatory electronic prescribing of controlled substances and improved prescription drug monitoring programs.