Articles related to FDA

This article from the American College of Physicians (ACP) provides a deeper dive into the pause of the J&J vaccine, which was recommended by the FDA and CDC on April 13, 2021, after six cases of cerebral venous sinus thrombosis (CVST) among patients who had received the vaccine was reported. The pause is being done to determine whether the vaccine is associated with any other types of thrombosis and to develop more specific recommendations for its use, possibly based on age.

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.