Eisai Co. on Sept. 27 began the application process for the Japanese drugmaker’s experimental drug lecanemab for early Alzheimer’s disease using an accelerated approval pathway, the same path that helped Eisai’s development partner Biogen Inc. win U.S. approval of its medication in June.
Two weeks after winning U.S. approval as a treatment for adults with Waldenstrom’s macroglobulinemia, BeiGene’s Brukinsa scored again as a treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL).
A study published in the BMJ suggests that about one-third of cancer indications receiving approval under an Accelerated Approval pathway are still on product labels even after follow-up studies did not confirm their benefits.
Eli Lilly will apply for U.S. health regulator’s accelerated approval during 2021 for the company’s experimental Alzheimer’s drug, weeks after Biogen Inc.’s controversial drug for the disease was approved.
The U.S. Food and Drug Administration approved Truseltiq (infigratinib) under the accelerated approval program for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement.
Opdivo Fails to Maintain Accelerated Approval in Liver CancerAccelerated Approval, Advisory Committees, Blockbusters, Clinical Trials, FDA, Hematocellular Carcinoma (HCC), Immunotherapies, Monoclonal Antibodies, Muscle-Invasive Urothelial Cancer (MIUC), Oncologic Drugs Advisory Committee (ODAC), Priority Review, R&D, Therapeutics
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee did not agree in a meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.
FDA Committee Supports Maintaining Accelerated Approval of Tecentriq in PD-L1+ mTNBCAccelerated 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.
The U.S. Food and Drug Administration granted accelerated approval of Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.
Six former FDA commissioners – Scott Gottlieb, Robert Califf, Mark McClellan, Margaret Hamburg, Jane Henney and Andrew von Escehenbach – signed a joint letter urging the U.S. president to nominate a permanent commissioner soon.
Roche’s Venclexta Granted Full Approval Under Project Orbis and Real-Time ReviewAccelerated Approval, Acute Myeloid Leukemia (AML), Adults 75 or older, Approvals, B-cell lymphoma-2 (BCL-2) protein, Chemotherapy, Clinical Trials, FDA/Regulatory, Full Approval, Project Orbis, R&D, Real-Time Oncology Review (RTOR) Pilot
The U.S. Food and Drug Administration granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.