External

Inbox

Search for all messages with label Inbox

Remove label Inbox from this conversation

December 27, 2024 11:59 AM EST PharmaFDA+
FDA approves subcutaneous version of Bristol Myers’ Opdivo
Kyle LaHucik
Senior Reporter
A decade after Bristol Myers Squibb first won approval for its PD-1 checkpoint inhibitor Opdivo, the cancer drug has been approved in a subcutaneous form that’s becoming a new area of competition for the blockbuster class.

Following Friday’s FDA approval, the under-the-skin injection will be sold as Opdivo Qvantig.

Wendy Short Bartie
Since Opdivo was originally cleared as an IV infusion in 2014, it has racked up approvals in more than 20 indications across 11 tumor types, Wendy Short Bartie, SVP of BMS’ US oncology & hematology commercialization, said in an interview with Endpoints News.

Subcutaneous formats are becoming the next battleground for the treatments, promising greater ease of use than infused drugs that must be given in a clinic. They could also extend the product life for the companies, giving them new patent protection.

“We believe that bringing subQ to the market ultimately allows patients to benefit from standard-of-care cancer medicine well into the next decade,” said Short Bartie.

advertisement

advertisement
Merck’s PD-1 inhibitor, Keytruda, was also first approved in 2014. The two drugs helped open the immunotherapy field and changed how cancer is treated. Keytruda, though, has blown past all others and pulled in $25 billion in 2023. Opdivo brought in $9 billion last year.

The subcutaneous form can be delivered in about three to five minutes versus 30 minutes for the IV form, Short Bartie said.

“Nobody wants to be constantly reminded that they have cancer, so what we’ve heard from patients is the ability to get in and get out of their doctor’s offices as quickly as possible allows people to get back to work, it allows them to spend more time with their families,” Short Bartie said.

Bristol Myers won’t be alone with its new version. Roche’s PD-L1 Tecentriq won a subcutaneous approval earlier this fall. And Merck reported positive Phase 3 data for its subcutaneous Keytruda last month and said it would discuss the results with global regulators “as soon as possible.”

“Overall, I believe, the approval of subcutaneous checkpoint inhibitors fundamentally improves care for patients, irrespective of which therapy the patient is on,” Short Bartie said.

The FDA approval of Opdivo’s new format is for previously approved adult solid tumor indications as a monotherapy; as a monotherapy after completion of Opdivo and Yervoy combination treatment; or in combination with chemotherapy or cabozantinib.

Short Bartie said BMS expects the subcutaneous approval will apply to about 75% of Opdivo’s business, but won’t apply to Opdivo-Yervoy combinations. And about 30% to 40% of eligible patients are anticipated to transfer from the IV formulation to the subcutaneous one, she said.

AUTHOR
Kyle LaHucik
Senior Reporter
[email protected]
@ky_lahucik