Pembrolizumab Approved: Solid Tumors With High Tumor Mutational Burden

The FDA granted accelerated approval to pembrolizumab (Keytruda®, Merck) for adults and children with previously treated unresectable or metastatic tumor mutational burden (TMB)–high solid tumors, defined as tumors with at least 10 mutations per megabase, who have no satisfactory alternative treatment option. The FDA also approved the FoundationOne® CDx assay (Foundation Medicine) as the companion diagnostic used to determine treatment eligibility. The approval was based on data from a prospecti...

Lurbinectedin Approved: Metastatic Small-Cell Lung Cancer

The FDA has granted accelerated approval to lurbinectedin (ZepzelcaTM, Pharma Mar, S.A.) for adults with metastatic small-cell lung cancer (SCLC) experiencing disease progression on or after platinum-based chemotherapy. The efficacy of lurbinectedin, a selective inhibitor of oncogenic transcription, was investigated in a multinational, single-arm, open-label phase 2 basket trial, PM1183-B-005-14 (Study B-005; NCT02454972), which enrolled adults with SCLC previously treated with only one chemothe...

FDA Oncology Approvals: Limitations In Clinical Trial Design

Fully two-thirds of anticancer drug clinical trials leading to FDA approvals over the course of a five-year period from 2014 to 2019 had at least one important limitation that could potentially impact the utility of the results, report the authors of an observational study published today in JAMA Internal Medicine. "Clinical trials leading to marketing authorization of anticancer drugs by the US Food and Drug Administration (FDA) are heterogeneous, with varying strengths and weaknesses," write t...

Febrile Neutropenia: FDA Approves Pegfilgrastim Biosimilar

The FDA has now approved pegfilgrastim-apgf (NyvepriaTM, Pfizer), a biosimilar of pegfilgrastim (Neulasta®, Amgen), for the prevention of febrile neutropenia in patients receiving myelosuppressive treatment for non-myeloid cancers. For patients with non-myeloid malignancies, chemotherapy and other anti-cancer medicines can often result in neutropenia, a condition involving an abnormally low number of neutrophils––a type of white blood cell––which increases the chance of life-threatening infectio...

Pomalidomide for Kaposi Sarcoma: Robert Yarchoan, MD

The FDA's recent accelerated approval of pomalidomide (Pomalyst®, Celgene) for Kaposi sarcoma in patients with and without HIV marked the first approval for this cancer in over 20 years. In this interview with i3 Health, Robert Yarchoan, MD, Chief of the HIV and AIDS Malignancy Branch at the National Cancer Institute (NCI) and principal investigator of the phase 1/2 Study 12-C-0047, which served as the basis for the approval, discusses pomalidomide's efficacy and safety, as well as additional re...

Subscribe

Get the latest updates delivered to your inbox!

Follow Us

Copyright © 2021 Oncology Data Advisor. All rights reserved.