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The following information helps you to find FDA Alerts and Pharmacist’s Applications to Practice quickly and easily. In cooperation with the Food and Drug Administration (FDA), and as a service to our members, HOPA periodically distributes information about newly approved therapies for cancer patients from FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur to inform oncologists and professionals in oncology-related fields in a timely manner. Links to product labels will take you to relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, HOPA does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

Along with HOPA’s Publications Committee, members also review new drug updates and provide analysis and research on the application of these new drugs or indications. Pharmacist’s Applications to Practice, or PAP, are listed after drugs that include the additional analysis. If you are interested in helping the Publications Committee with creating a Pharmacist's Application to Practice, please contact Jeff Price at jprice@hoparx.org.

You can also find additional information on FDA Alerts and Updates by listening to FDA Drug Safety Podcasts.

February 22, 2019–Trifluridine/ tipiracil tablets (LONSURF, Taiho Pharmaceutical Co., Ltd.)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

September 22, 2015–Trifluridine/tipiracil (LONSURF, Taiho Oncology, Inc.) for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- , and irinotecan-based chemotherapy, an anti-VEGF biologic product, and an anti-EGFR monoclonal antibody, if RAS wild-type


February 22, 2019

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207981s008lbl.pdf

On February 22, 2019, the Food and Drug Administration approved trifluridine/ tipiracil tablets (LONSURF, Taiho Pharmaceutical Co., Ltd.)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

Approval was based on TAGS (NCT02500043), an international, randomized, double-blind, placebo-controlled trial in 507 patients with metastatic gastric or GEJ adenocarcinoma previously treated with at least two prior lines of chemotherapy. Patients were randomized 2:1 to receive Lonsurf (n=337) 35 mg/m2 orally twice daily on Days 1-5 and 8-12 of each 28-day cycle with best supportive care (BSC) or matching placebo (n=170) with BSC until disease progression or unacceptable toxicity.

Median overall survival was 5.7 months (4.8, 6.2) for patients receiving Lonsurf and 3.6 months (3.1, 4.1) for those receiving placebo (hazard ratio: 0.69; 95% CI: 0.56, 0.85; p=0.0006). Progression-free survival was also longer in patients randomized to the Lonsurf arm (hazard ratio 0.56; 95% CI: 0.46, 0.68; p<0.0001).

In the TAGS trial, the most common adverse reactions or laboratory abnormalities (≥10% incidence) in patients treated with Lonsurf occurring at a higher rate than in patients receiving placebo were neutropenia, anemia, nausea, decreased appetite, thrombocytopenia, vomiting, and diarrhea.

The recommended Lonsurf dose and schedule is 35 mg/m2/dose orally twice daily with food on Days 1 through 5 and Days 8 through 12 of each 28-day cycle.

View full prescribing information for LONSURF.

FDA granted this application priority review and orphan drug designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.


September 22, 2015

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207981s000lbl.pdf

On September 22, 2015, the U. S. Food and Drug Administration approved trifluridine/tipiracil (LONSURF, Taiho Oncology, Inc.) for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- , and irinotecan-based chemotherapy, an anti-VEGF biologic product, and an anti-EGFR monoclonal antibody, if RAS wild-type.

The approval was based on the demonstration of improved overall survival (OS) in a multicenter, double-blind, placebo-controlled trial (TPU-TAS-102-301). A total of 800 patients with previously treated metastatic colorectal cancer were randomly allocated (2:1) to receive trifluridine/tipiracil (N=534) plus best supportive care (BSC) or matching placebo (N=266) plus BSC. Key eligibility criteria included ECOG 0-1, absence of brain metastasis, and absence of ascites requiring drainage in the past four weeks. Patients received 35 mg/m2 trifluridine/tipiracil (based on trifluridine component) or matching placebo orally twice daily on days 1 - 5 and 8 – 12 of each 28-day cycle until disease progression or unacceptable toxicity.

A statistically significant improvement in OS was demonstrated [HR 0.68 (95% CI: 0.58, 0.81), p<0.001, stratified log-rank test]; the median OS was 7.1 and 5.3 months in the trifluridine/tipiracil and placebo arms, respectively. PFS was also improved in patients randomly allocated to receive trifluridine/tipiracil [HR 0.47 (95% CI: 0.40, 0.55), p<0.001, stratified log-rank test].

The most common adverse drug reactions or laboratory abnormalities were anemia, neutropenia, asthenia/fatigue, nausea, thrombocytopenia, decreased appetite, diarrhea, vomiting, abdominal pain, and pyrexia. The most common adverse reactions leading to dose reduction were neutropenia, anemia, febrile neutropenia, fatigue, and diarrhea.

The recommended dose and schedule for trifluridine/tipiracil is 35 mg/m2 (based on trifluridine component) orally twice daily within one hour of completion of morning and evening meals on days 1 through 5 and days 8 through 12 of each 28-day cycle until disease progression or unacceptable toxicity.

Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207981s000lbl.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

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