FDA Approves Second Tissue-Agnostic Drug; Refund Is Available

By Angela Maas

As the FDA continues to approve drugs targeted toward specific biomarkers, the agency has granted accelerated approval to another tissue-agnostic oncology treatment. While the gene fusion is fairly rare, Loxo Oncology, Inc. and Bayer Corp.'s Vitrakvi (larotrectinib) has shown high overall response rates across multiple solid tumors. Not surprisingly, the medication comes with a high price tag — but also a refund for qualified patients who do not respond within three months of initiating treatment.

On Nov. 26, the FDA gave accelerated approval to Vitrakvi for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have no satisfactory alternative therapies or that have progressed after treatment.
"It definitely is an exciting development within the oncology treatment arena, but where it's going to fit into treatment" in terms of guidelines and protocols "is yet to be seen," says Beckie Fenrick, Pharm.D., senior partner at RemedyOne.

The drug is available as a capsule, dosed at 100 mg twice daily, as well as a liquid formulation for certain pediatric patients, with dosing 100 mg/m2 twice daily. Bayer set the monthly wholesale acquisition cost for a 30-day supply of 100 mg capsules at $32,800, and the WAC for the liquid formulation at $11,000 monthly.

Multiple programs through TRAK Assist are in place to help people afford the medication:

• TRAK Assist $0 Co-Pay Program will be available for eligible patients with commercial or private insurance.
• VITRAKVI Bridge Program will provide the drug for free to people who have coverage delayed or who have a temporary coverage lapse during the period without coverage.
• TRAK Assist will refer publicly insured patients to third-party assistance programs.
• A patient assistance foundation will help qualified uninsured or underinsured people.

In addition, in a situation where a patient does not have a clinical benefit within 90 days of starting the drug, the cost of up to two months of Vitrakvi will be refunded to each entity that made a payment for the drug — patients, payers and third-party organizations — through the Vitrakvi Commitment Program.

From RADAR on Specialty Pharmacy