U.S. indication of Tecentriq® for the treatment of cisplatin-ineligible, PD-L1+ve adults with locally advanced or mUC to be withdrawn

“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner. We remain confident in the benefit Tecentriq offers to people diagnosed with some of the most difficult-to-treat forms of cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival.”

Share:

More News

“Between 2017 and 2023, the socioeconomic burden of HER2-positive breast cancer in ten major economies was nearly $590 billion, projected to increase to nearly $1,000 billion by 2032,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “At-home treatment may help alleviate the pressure

Richard Saynor, CEO of Sandoz, said: “The global burden of cancer continues to grow and the potential to address unmet patient needs has never been greater. This agreement offers us the chance to reach many more millions of patients, while helping to drive the long-term sustainability of healthcare systems.”

“Beyond the second-line monotherapy opportunity, we and our partners at Pfizer have removed plans for a Phase 3 first-line combination trial with atirmociclib, as well as the planned Phase 3 second-line combination trial with a CDK4/6 inhibitor, from our joint development plan,” continued Dr. Houston. “This decision was made following

“The interim PFS analysis results demonstrated that, compared to the current standard treatment, KN026 in combination with chemotherapy significantly improved PFS, reduced the risk of disease progression or death, and showed a trend toward OS benefit. Detailed data from this study will be presented at an upcoming international academic conference.”