Mikkael A. Sekeres, MD, currently Chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center at the University of Miami, worked on the decision to remove Avastin’s indication for the treatment of HER2-negative metastatic breast cancer in 2008. As a result of the hearing, Dr. Sekeres poses the following question in his most recent book, Drugs and the FDA: Safety, Efficacy, and the Public’s Trust: “Had the FDA made a mistake in initially approving the drug?” Dr. Sekeres discussed with OBR the rise of accelerated approvals, progression-free survival as an endpoint, and the consequences of the Avastin hearing.

With the initial attempt at salvage therapy, the median PFS was 3.5 months. The objective response rate (ORR) for these patients was 43.4%, with strict complete responses (9.2%), very good partial responses (11.8%), and partial responses (22.4%) all being achieved by patients. A significantly longer median OS of 29.9 months compared to 14.6 months for patients who did not achieve an objective response was associated with achieving a partial response or better with the first line of salvage therapy.

Judith Trotman, MBChB, FRACP, FRCPA, clinical professor at the University of Sydney in Concord, New South Wales, Australia, and head of the Hematology Department at Concord Repatriation General Hospital, provides background on mantle cell lymphoma, its unique treatment challenges, and the significance of the SHINE trial, which assessed ibrutinib plus bendamustine and rituximab in untreated mantle cell lymphoma.

Amar Gajjar, MD, who serves as the co-chair of the oncology department and chair of the pediatric medicine department at St. Jude Children’s Research Hospital in Memphis, Tennessee, answers questions from our friends at Cancer Therapy Advisor. Proton therapy, conventional chemotherapy, targeted therapies, and observed glioma progression are all topics covered by Dr. Gajjar when talking about treatment options for pediatric low-grade gliomas (pLGG) that have relapsed or progressed.

The “super enhancer,” a complex region of DNA with a lot of transcriptional machinery that determines whether a cell is malignant, can be programmed by the environment around a colon cancer tumor for the first time, according to research. The PDZK1IP1 gene, which was not previously recognized as a cancer gene, is controlled by this super enhancer, which is the biggest 1-2% of all enhancers in the cell. Colon cancer growth was inhibited when PDZK1IP1 was deleted, indicating that PDZK1IP1 and its super enhancer may be targets for cancer treatments.

In this cohort study of 12,046 patients with cancer and COVID-19, it was discovered that the use of immunotherapy (IO) and other systemic anticancer therapies in combination with baseline immunosuppression was linked to worse outcomes and a higher incidence of cytokine storm in SARS-CoV-2-infected cancer patients.