Bristol Myers Squibb Seeks Expanded Approval for Opdivo in Bladder Cancer Patients

Bristol Myers Squibb has received a priority review from the FDA for its application to expand the approval of Opdivo, a widely used cancer drug, in certain patients with bladder cancer. The application specifically covers the use of Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adults with bladder cancer that cannot be surgically removed or has spread to other parts of the body.

The FDA grants priority review to medications that have the potential to significantly improve the treatment of a serious disease, and this designation allows for a shorter review period. The regulator has set a target action date of April 5 for Bristol Myers Squibb's application. If approved, the Opdivo-based regimen would become the first immunotherapy-chemotherapy combination to be approved for this specific patient population in the U.S.

Opdivo, a groundbreaking immunotherapy drug that activates the body's own immune system to fight cancer, is already approved in over 65 countries for various types of cancers. In the first nine months of 2023, Opdivo generated an impressive revenue of more than $6.6 billion.