Bristol Myers Squibb’s cancer drug, Opdivo, has been approved by the US Food and Drug Administration (FDA) in an injectable form. The new subcutaneous version, branded as Opdivo Qvantig, is expected to be more convenient for patients and help shield the company from erosion of sales when the patent on the intravenous version expires later this decade.
Opdivo Qvantig is approved to treat all previously approved adult solid tumor indications, either alone or in combination with chemotherapy. The approval was based on data from a late-stage study that showed the subcutaneous form was not inferior to the intravenous formulation in patients with advanced kidney cancer who have received prior systemic therapy.
The injectable version uses Halozyme Therapeutics’ drug delivery technology, which reduces treatment administration time from hours-long IV infusions to minutes. The new Opdivo Qvantig is expected to be priced at parity with the list price of the IV version, currently $7,635 per infusion for two weeks and $15,269 per infusion for four weeks.
The approval marks a significant development in Bristol Myers Squibb’s efforts to drive growth through newer treatments like Opdivo Qvantig, as patents on older drugs such as Revlimid and Eliquis expire later this decade.
Source: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-injectable-form-bristol-myers-opdivo-2024-12-27