FDA grants tentative approval for first generic of Vitrakvi

The FDA has granted tentative approval for larotrectinib 25 mg and 100 mg capsules, Alembic Pharmaceuticals’ generic of Vitrakvi. Larotrectinib is a kinase inhibitor used to treat adult and pediatric patients with solid tumors that are positive for neurotrophic receptor tyrosine kinase (NTRK) gene fusions.

NTRK gene fusions can play a role in the development of cancer. They are rare in patients with solid tumors with less than 1% of patients testing positive. Larotrectinib is designed to target and inhibit the TRK family of proteins, regardless of where the tumor is.

Vitrakvi was developed by Loxo Oncology and is marketed by Bayer Pharmaceuticals. Lilly later acquired Loxo and Bayer maintained rights to Vitrakvi. Vitrakvi had been granted accelerated approval in November 2018, with full approval granted in April 2025. It was the first drug approved as a tumor agnostic therapy. The wholesale acquisition cost of Vitrakvi is $270 per 25 mg capsule. The dosage is 100 mg orally, twice daily.

Alembic Pharmaceuticals’ larotrectinib is the first generic of Vitrakvi and is eligible for 180 days of marketing exclusivity in the United States when granted final approval.

Larotrectinib capsules have an estimated market size of $91 million for the 12 months ending March 2026, according to IQVIA.