Biosimilars: What&#x27;s in a Name?

FDA Approves Amgen’s Lumakras Plus Vectibix for KRAS G12C-Mutated Metastatic Colorectal Cancer

Approval is based on results from the TROPION-Breast01 Phase III trial, in which Datroway demonstrated a significant reduction in the risk of disease progression or death in patients with previously treated, unresectable, or metastatic HR-positive, HER2-negative breast cancer.

FDA Approves AstraZeneca’s Calquence for Previously Untreated Mantle Cell Lymphoma

Approval is based on data from the Phase III CodeBreaK 300 trial, which demonstrated that treatment with Lumakras and Vectibix significantly improved progression-free survival in patients with KRAS G12C-mutated metastatic colorectal cancer.

January 17th 2025

FDA Approves Incyte and Syndax’s Niktimvo for Chronic Graft-Versus-Host Disease in 9 and 22 mg Vial Sizes

Approval follows results from the Phase III ECHO trial, which demonstrated that Calquence plus chemotherapy reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.

FDA Approves Eli Lilly’s Omvoh for Crohn Disease

Niktimvo marks the first FDA-approved therapy targeting CSF-1R to address inflammation and fibrosis in chronic graft-versus-host disease.

Johnson & Johnson Initiates New Drug Application for TAR-200 in BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer

Approval was based on results of the VIVID-1 study, which found that Omvoh demonstrated significant clinical remission and endoscopic response rates in patients with Crohn disease.

January 15th 2025

FDA Approves AstraZeneca, Daiichi Sankyo’s Datroway for Previously Untreated Unresectable, Metastatic HR-Positive, HER2-Negative Breast Cancer

The New Drug Application for TAR-200 is supported by results from the Phase IIb SunRISe-1 study, which demonstrated an 83.5% complete response in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer.

Related Content

FDA Approves Amgen’s Lumakras Plus Vectibix for KRAS G12C-Mutated Metastatic Colorectal Cancer

FDA Approves AstraZeneca’s Calquence for Previously Untreated Mantle Cell Lymphoma

January 17th 2025

FDA Approves Incyte and Syndax’s Niktimvo for Chronic Graft-Versus-Host Disease in 9 and 22 mg Vial Sizes

FDA Approves Eli Lilly’s Omvoh for Crohn Disease

Niktimvo marks the first FDA-approved therapy targeting CSF-1R to address inflammation and fibrosis in chronic graft-versus-host disease.

Johnson & Johnson Initiates New Drug Application for TAR-200 in BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer

Approval was based on results of the VIVID-1 study, which found that Omvoh demonstrated significant clinical remission and endoscopic response rates in patients with Crohn disease.