Oncologic Drugs Advisory Committee (ODAC) Archives

FDA Committee Supports Maintaining Accelerated Approval of Tecentriq in PD-L1+ mTNBC

Accelerated Approval, Blockbusters, Checkpoint Inhibitors, FDA, Genentech, Oncologic Drugs Advisory Committee (ODAC), PD-1/PD-L1 inhibitors, Recommended For Approval, Therapeutics, Triple Negative Breast Cancer (TNBC)

A U.S. Food and Drug Administration committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.

FDA says to review side effect of GSK’s multiple myeloma drug

Clinical Trials, FDA, FDA/Regulatory, Multiple myeloma, Oncologic Drugs Advisory Committee (ODAC), R&D, Side Effects

The U.S. Food and Drug Administration will review GlaxoSmithKline’s experimental treatment for multiple myeloma, a common form of blood cancer, for a reported side effect which affects the eyes of patients.

Eli Lilly’s Cyramza Passes FDA Advisory Hurdle for NSCLC

EGFR Mutations, Lancet Oncology, Non-Small Cell Lung Cancer (NSCLC), Oncologic Drugs Advisory Committee (ODAC), Untreated Metastatic EGFR-Positive Non-Small Cell Lung Cancer (NSCLC)

Indianapolis-based Eli Lilly announced the FDA’s Oncologic Drugs Advisory Committee voted 6-5 in favor of Cyramza (ramucirumab) plus erlotinib as a potential treatment for patients with untreated metastatic EGFR-positive non-small cell lung cancer (NSCLC).