Articles related to Hematology/Oncology

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.

In this Original Investigation from JAMA Oncology, the authors seek to discover the characteristics that define modern randomized clinical trials (RCTs) in oncology and whether they differ from characteristics of RCTs from the preceding decades, as concerns have emerged regarding the use of putative surrogate end points, such as progression-free survival (PFS) and marginal effect sizes.

The data, concluded in a report posted to the preprint server medRxiv, support prioritization of cancer patients for an early (21-day) second dose of the BNT162b2 vaccine, as barely one-quarter of patients with cancer obtained protection (28% immune efficacy rate, including 13% in patients with blood cancers) against COVID-19 after one dose of the Pfizer/BioNTech vaccine.

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).

More good news for zanubrutinib, which received accelerated approval in November 2019 in the US for the treatment of mantle cell lymphoma (MCL) in adult patients who have undergone at least one prior therapy. The supplemental new drug application (sNDA) was submitted by the drug’s manufacturer, BeiGene, based on data from the global phase III ASPEN trial.