Articles related to FDA

This new indication marks the second FDA approval for sacituzumab govitecan (Trodelvy, Immunomedics) and was based on the phase 2, single-arm TROPHY-U-01 main efficacy endpoints in objective response rate (ORR) and duration of response (DOR). With a relative 5-year survival rate of 5.5%, this is a significant advancement for patients with metastatic urothelial cancer (mUC), the most common type of bladder cancer.

The approval of the new cetuximab (Erbitux) dosage – 500 mg/m2 as a two-hour IV infusion every two weeks – was based on population pharmacokinetic (PK) modeling analyses and provides an alternative option to the previously approved weekly dose. Cetuximab can be dosed alone or in combination with chemotherapy.

From the pages of Oncology Times comes the latest approvals, designations, and new indications from the U.S. Food and Drug Administration (FDA) for oncology drugs. Stories include new approvals in multiple myeloma, esophageal or gastroesophageal junction (GEJ) carcinoma, non-small cell lung cancer (NSCLC), anaplastic lymphoma, and more.

The FDA’s Oncologic Drugs Advisory Committee will hold a public meeting from April 27 to 29, 2020, to reevaluate six treatments that were previously granted accelerated approval and have since reported results that failed to verify clinical benefit. The six indications to be discussed include atezolizumab (two indications), pembrolizumab (three indications), and nivolumab (one indication).

The FDA announced a trial hold after two participants with sickle cell disease (SCD) in the LentiGlobin gene therapy trials developed AML and MDS. According to bluebird bio, the manufacturer of LentiGlobin products, the company was unable to find any cancer cells in the patient’s bone marrow and has asked the FDA for permission to resume clinical trials.

The approval of the drug (Fotivda, Aveo Pharmaceuticals) was based on the results of the open-label, multi-center TIVO-3 trial, which looked at progression-free survival (PFS) as the main efficacy endpoint, assessed by a blinded independent radiology review committee. Secondary end points included overall survival (OS) and objective response rate (ORR).