FDA Approves New Colorectal Cancer Treatment

The FDA recently granted another approval to Taiho Pharmaceutical Co., Ltd. division Taiho Oncology, Inc.’s Lonsurf (trifluridine/tipiracil) for a type of colorectal cancer. The decision provides another treatment option for a condition that respondents to a Zitter Insights survey regard as in need of more effective therapies.

On Aug. 2, the FDA approved Lonsurf as a single agent or in combination with bevacizumab for the treatment of adults with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) drug and, if Rat sarcoma (RAS) wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The agency first approved the oral nucleoside antitumor agent on Sept. 22, 2015. The newest use had priority review. Dosing for the tablet is 35 mg/m2 twice daily on days one through five and days eight through 12 of each 28-day cycle. Drugs.com lists the price of 20 6.14 mg/15 mg tablets as more than $4,204.

According to Marwan Fakih, M.D., a professor in the department of medical oncology and therapeutics research at City of Hope and the lead U.S. investigator for the Phase 3 SUNLIGHT trial that evaluated this new use, the approval gives people with metastatic colorectal cancer “an important new treatment option, one that has been shown to extend life in addition to other benefits and which I believe will change the treatment landscape for this patient population.” He added that Lonsurf plus bevacizumab “did not result in an increase in potentially intolerable side effects that might limit the utility of this combination.”

For the Managed Care Oncology Index: Q4 2022, from Nov. 21, 2022, to Dec. 22, 2022, Zitter Insights polled 34 commercial payers covering 120.8 million lives, 25 Medicare payers representing 40.5 million lives and 100 oncologists about their management and prescribing of colorectal cancer therapies. Commercial payers with 85% of lives, Medicare payers with 40% of lives and 56% of oncologists expressed average satisfaction with current treatments. No payers and only 4% of oncologists said they were extremely satisfied with the available options.

Both AIS Health and Zitter Insights are divisions of MMIT.

Payers with the most lives said that agents to treat the disease have an average to high impact on their budget. Respondents covering almost all Medicare beneficiaries said that there is a high or very high disease burden for people with the disease.

Payers varied somewhat in the level of aggressiveness in managing branded products for colorectal cancer, although those with 41% of commercial beneficiaries and 46% of Medicare lives said their approach was slightly aggressive. Payers with 65% of commercial lives and 87% of Medicare lives rated managing branded treatments for the condition as a high priority (see chart).

For more information on the Zitter Insights data, contact Jill Brown Kettler at jkettler@mmitnetwork.com.


© 2024 MMIT
Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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