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indication of Tecentriq® for the treatment of cisplatin-ineligible, PD-L1+ve adults with locally advanced or mUC to be withdrawn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
Lamine Mbow, Global Head of Discovery Research, Boehringer Ingelheim, said: “We are building a broad pipeline of ADCs addressing novel tumor target space to develop next-generation cancer treatments. By combining our deep expertise in cancer treatment development with Synaffix’s clinical-stage platform technology, we aim to accelerate the delivery of first-in-class
“The initial therapy of high-risk, non-muscle invasive bladder cancer with BCG has not advanced in decades. Today’s pivotal Phase 3 CREST results are potentially practice-changing, representing the first advance in therapy for BCG-naïve, high-risk, non-muscle invasive cancer in over 30 years,” said Roger Dansey, M.D., Chief Oncology Officer, Pfizer. “These
“Receiving FDA IND clearance is an important milestone in the advancement of TYRA-300 and for patients with NMIBC who urgently need better tolerated therapeutic options,” commented Doug Warner, Chief Medical Officer of TYRA. “We look forward to leveraging Erik’s impressive background to guide our development plans in NMIBC. We expect
“As a leader in hematologic malignancies, AbbVie is committed to advancing innovative treatments for complex cancers like multiple myeloma through our relentless R&D efforts and collaborations,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “We look forward to partnering with Simcere Zaiming, to advance
