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Taiho's NDA for mCRC Under FDA Review
The TAS-102 RECOURSE trial met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo, and the results of the trial form the basis of the NDA.
Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced the New Drug Application (NDA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), has been accepted for review by the FDA. TAS-102 is an oral combination investigational anticancer drug for the treatment of refractory metastatic colorectal cancer (mCRC).
"The FDA's filing of the TAS-102 NDA represents a significant milestone for our company and underscores the need for new treatment options for patients with refractory metastatic colorectal cancer," said Eric Benn, Taiho Oncology's president and chief executive officer. "Today, we are one step closer to our ultimate goal of gaining regulatory approval for TAS-102 and making it available to patients in the USA with this serious medical condition. We look forward to working closely with the FDA during the NDA review."
Link to the complete article: http://bit.ly/1A0WOT2
Source: News Medical
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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Texas Oncology to Roll Out Canopy for ePROs After Head-to-Head Pilot
March 18th 2025Debra Patt, MD, PhD, MBA, executive vice president of Public Policy and Strategy for Texas Oncology, said the practice received positive feedback from nurses and patients during a pilot that concluded in February.
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Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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