FDA Approves Lonsurf® (TAS-102)

The FDA has approved the use of Lonsurf as a treatment for metastatic colorectal cancer. This new drug gives patients another treatment option when they stop responding to other chemotherapy or biologic treatments.

What is Lonsurf?

Lonsurf is an oral chemotherapy drug available by prescription for treatment of metastatic colorectal cancer. Lonsfurf is a nucleoside-analogue drug developed by Taiho Oncology. It primarily incorporates itself into the DNA of cancer cells, stopping them from growing.

Prior to this drug being FDA approved, everyone called it TAS-102. Is there a reason for the shift to now calling it Lonsurf?

When the drug was in its investigational phase, it was referred to as TAS-102. Now that the drug has been FDA approved, the official name is Lonsurf.

Who is a candidate for Lonsurf?

Patients who have previously received and are no longer responding to other chemotherapy and biologics may be eligible to be treated with Lonsurf. Additionally, the RECOURSE trial (published in New England Journal of Medicine) confirmed that Lonsurf also benefited patients who had mutated and non-mutated KRAS genes.

Patients who take Stivarga are part of a similar patient profile as those who can take Lonsurf. Are there any main differences between the drugs?

These drugs are for patients at a similar stage in treatment. However, they attack the cancerous cells in different ways. Additionally, the potential side effects as a result of taking the drugs are different. Consult your medical provider to determine the best course of treatment for you.

In which ways is the new drug different than what is currently available for patients?

Lonsurf is unique in that it combines two drugs, trifluridine and tipiracil. In the past when a patient’s disease progressed after treatment with standard therapies, there were limited options for further treatment. With the approval of Lonsurf, patients have an additional option to consider.

How much of a survival advantage does this give me than what is already available?

Everyone’s body is different and it’s hard to answer this question. However, in the RECOURSE study, patients treated with TAS-102 lived an average of 7.1 months compared to 5.3 months for those treated with the placebo control arm.

What are the most common side effects? How can I be best prepared to handle these side effects?

The FDA reports the most common side effects are anemia, neutropenia (decrease in white blood cells that help fight infection or blood platelets – known as thrombocytopenia) as well as fatigue, nausea, diarrhea, decreased appetite, abdominal pain and fever. These potential side effects make it increasingly important to have your blood counts tested prior to beginning treatment, at day 15 in your treatment plan and prior to beginning another cycle. In pregnant females, Lonsurf may cause fetal harm. It is important to note that patients who are on Lonsurf were previously on other chemotherapy drugs and may have lingering side effects from their prior treatment plan. Patients who have been on this drug have told us they found it easier to tolerate than some other chemotherapy combinations.

Is it infused or a pill? If a pill, how often will I need to take it?

This drug is an oral chemotherapy and taken in pill form. Patients should follow the schedule prescribed by their doctor. A common schedule for taking the drug is:

Day 1 – 5: twice daily after meals

Day 6 – 7; no pills

Day 8 – 12: twice daily after meals

Day 13-14: no pills

Day 15-28: no pills

Be sure to take blood counts on day 15 and prior to beginning your next treatment cycle to assure low drug toxicity.

Will my insurance cover this new drug?

With the FDA approval of Lonsurf, insurance will approve the expense per the guidelines of the individual’s health plan. Be sure to work with your provider on establishing what your benefit guidelines are.

How much would Lonsurf cost out-of-pocket?

The out-of-pocket cost will vary with your insurance plan.

Is there a copay/financial help relief program? How do I access it?

Taiho Oncology does have a copay assistance program available to patients:

Commercially insured: Taiho Oncology wants to assure that no one will pay more than $30 out-of-pocket for Lonsurf per cycle.

Medicare or Medicaid: In order to support this patient population, they will be working with patient service organizations to provide copay financial assistance.

Uninsured: For patients who are uninsured, Taiho Oncology has a program to provide  Lonsurf free of charge to qualified individuals. A patient with a family of 4 can have an approximate annual income $121,000 and still be eligible. As an individual, your income cannot exceed approximately $58,000.

They also have personalized nurse support available. For more information about all of these programs, please visit: taihopatientsupport.com or call (844) 824-4648.

Questions? We’re here to help. Check out the original press release for more specifics about this new approval and pose your questions in the comments. We’ll do our best to get them answered! Don’t forget, the Colon Cancer Alliance serves as a source of information about colon health. If you have questions or are in need of support, please contact our free Helpline at (877) 422-2030.

The Colon Cancer Alliance provides patients and the general public with vital information about colorectal cancer, its prevention and treatment. These Colon Health Alerts are sent whenever there is approval of new treatments or devices, significant advances in research or other timely and relevant updates related to the Colon Cancer Alliance mission. Reference herein to any specific commercial products, process or service by trade name, trademark, manufacturer or otherwise, does not constitute or imply its endorsement, recommendation or favoring by the Colon Cancer Alliance. The information provided in this Alert is designed to help empower patients and does not replace the direct relationship between patients and health professionals. Patients should not make any healthcare decisions based on information in this Alert without first contacting your physician or healthcare professional.

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