The U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.
The Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended that Eli Lilly and Co. and Innovent Biologics Inc. conduct a clinical trial applicable to the U.S. population for the lung cancer drug sintilimab. The U.S. FDA previously raised concerns over a clinical trial conducted entirely in China focused on a single ethnic group.
Researchers studying Merck & Co. Inc.’s cancer drug Keytruda for HIV patients who also have cancer say the immunotherapy may help displace the virus from human immune cells, offering an intriguing area of study for treatment of chronic HIV infection.
Junshi Biosciences announced that the Phase III clinical trial the Chinese pharmaceutical company is conducting alongside California-based Coherus BioSciences on a potential non-small cell lung cancer (NSCLC) drug is showing positive preliminary results.
The U.S. Food and Drug Administration approved the combination of Merck’s anti-PD-1 therapy Keytruda plus Eisai’s orally available multiple receptor tyrosine kinase inhibitor Lenvima for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
Findings from the Phase III EMPOWER-Lung 3 trial, announced Aug. 5 by Regeneron Pharmaceuticals and Sanofi, show that a combination regimen comprising the PD-1 inhibitor Libtayo and platinum-doublet chemotherapy significantly improved overall survival compared with chemotherapy alone in patients with metastatic or locally advanced non-small cell lung cancer (NSCLC).
The U.S. Food and Drug Administration approved an expanded label for Merck’s anti-PD-1 therapy Keytruda as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration, voted 13-4 that a regulatory decision on Incyte’s PD-1 inhibitor retifanlimab for the treatment of advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) should be deferred until further data are available from the clinical trial POD1UM-303.
Regeneron and Sanofi broke new ground in treating advanced basal cell carcinoma with their anti-PD-1 inhibitor, Libtayo.
Merck announced positive data from the Phase III KEYNOTE-355 trial looking at the company’s checkpoint inhibitor Keytruda (pembrolizumab) in combination with chemotherapy as a first-line treatment for metastatic triple-negative breast cancer.