FDA Approves Expanded Indication for KEYTRUDA Plus Padcev for 1L Treatment of Adult Patients With Locally Advanced or Metastatic Urothelial Cancer
“Advanced bladder cancer is a common cause of cancer-related death,” said Dr. Thomas Powles, primary investigator of KEYNOTE-A39, professor of Genitourinary Oncology and director, Barts Cancer Center. “The overall survival benefit seen in the KEYNOTE-A39 trial demonstrates the potential for KEYTRUDA in combination with enfortumab vedotin to impact the first-line treatment of patients with locally advanced or metastatic urothelial cancer. In my opinion, this is a meaningful advancement over platinum-based chemotherapy in the systemic treatment of these patients.”
Share:
More News
PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission
“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is
