The FDA has shortened the timeline for coming to a decision on Bristol Myers Squibb’s subcutaneous version of its blockbuster PD-1 inhibitor Opdivo.
The company announced Tuesday that the therapy’s new PDUFA date is Dec. 29, 2024, moved up from Feb. 28, 2025. If the FDA approves subcutaneous Opdivo, it would be available in all of the solid tumors that the IV version is already approved in as a monotherapy, monotherapy maintenance following the completion of Opdivo plus Yervoy, or in combination with chemotherapy or cabozantinib, the company said.
An approval would also mean Opdivo would be the first and only subcutaneous PD-1 inhibitor on the market. Since 2014, Opdivo has competed fiercely with Merck’s blockbuster PD-1 Keytruda. Merck said it would provide an update later this year on subcutaneous Keytruda, according to an April note from Leerink Partners.
Bristol Myers’ application for subcutaneous Opdivo includes data from the 495-patient Phase 3 CheckMate -67T, which pitted the subcutaneous and IV versions against each other in participants with advanced or metastatic clear cell renal cell carcinoma who have received prior therapies.
Opdivo brought in $1.2 billion in revenues in the first quarter of 2024 for Bristol Myers and $9 billion in 2023. The drug is facing future competition, with Amgen working on a Phase III trial for its potential biosimilar to the drug, as well as a Phase 1 study comparing its biosimilar to Opdivo in resected stage III or stage IV melanoma patients.
But Bristol Myers previously predicted that it will not see its exclusivity on Opdivo fade away until 2028, and not until 2030 in the EU.
Opdivo scored its latest approval in March, this time in combination with the chemotherapies cisplatin and gemcitabine to treat adults with unresectable or metastatic urothelial carcinoma. Also in March, the company said it would talk with regulatory authorities for its Opdivo-Yervoy combo in the first-line setting for advanced liver cancer following positive Phase 3 data.