FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX™, Each in Combination with Padcev, for Cisplatin-ineligible Patients with MIBC

“New options for muscle-invasive bladder cancer are vital — patients who are ineligible for chemotherapy have not seen a treatment advance beyond surgery in decades,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “With the FDA’s priority review, we are one step closer to offering KEYTRUDA or KEYTRUDA QLEX plus Padcev as a potential treatment option to these patients with MIBC who are ineligible for cisplatin-containing chemotherapy and have such high unmet medical need.”

Share:

More News

“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy

“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of

“Whitehawk has established strong expertise in ADC technology and oncology drug development,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data