News

The FDA has accepted a supplemental Biologics License Application for axicabtagene ciloleucel for the treatment of patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma after 2 or more prior lines of systemic therapy.

In the first reported trial of an immune checkpoint inhibitor with chemotherapy in patients with treatment naïve malignant pleural mesothelioma, durvalumab in combination with cisplatin and pemetrexed demonstrated clinical activity and tolerability, according to published study.

In an interview with Targeted Oncology, David E. Gilham, PhD, discussed the findings from the single vector multiplexed short-hairpin RNA approach to concurrently knockdown the expression of multiple genes in chimeric antigen receptor T cells when used as treatment of patients with cancer.

A statistically significant overall survival benefit was not observed with osimertinib compared with platinum-pemetrexed therapy as treatment of patients with EGFR T790M-mutated advanced non–small cell lung cancer.

The most common genetic cause of alterations in pediatric patients with papillary thyroid cancer were fusion genes, which were associated with more aggressive disease.

The American Society of Clinical Oncology gathered the most recent data on the supply of oncologist in comparison to the demand for them in the United States. A significant shortage of specialists was discovered.

The benefits and risks of osimertinib as second- or later-line treatment of patients with EGFR-positive non–small cell lung cancer that were reported when the agent was first approved, have now been confirmed, according to data from a real-world study conducted in Japan.

Sequential afatinib followed by osimertinib led to encouraging outcomes in patients with deletion 19 (del19) or L858R epidermal growth factor receptor (EGFR)-mutant non–small cell lung cancer, according to the final analysis results from the real-world study, GioTag.

The FDA has granted an Orphan Drug designation to rhenium nanoLiposomes for the treatment of patients with recurrent glioblastoma.

In an interview with Targeted Oncology, Maria E. Cabanillas, MD, discussed the evolution she has observed in thyroid cancer in terms of the use of targeted therapies and other important milestones for this patient population.

The survival outcomes observed in this study further supported the biosimilarity between bevacizumab and SB8.

A real-world study assessed the performance of this system in patients with differentiated thyroid cancer and discovered that the system is reliable for predicting short-term outcomes.

RAS status detected in circulating tumor DNA was associated significantly with clinical outcomes when patients with metastatic colorectal cancer were rechallenged with anti-EGFR monoclonal antibody therapy of either cetuximab or panitumumab, according to findings from a clinical study evaluating RAS mutational status in ctDNA using the OncoBEAM RAS CRC test kit in 2 Japanese multicenter, prospective studies.

The FDA granted approval to the oral hypomethylating agent, CC-486 (azacitidine tablets, Onureg), as a maintenance treatment for adult patients with acute myeloid leukemia who achieved a first complete remission or with incomplete blood count recovery after intensive induction chemotherapy and who are unable to complete intensive curative therapy.

The question of whether patients with asymptomatic advanced-stage follicular lymphoma should undergo watch-and-wait observation or start treatment immediately was addressed at the 2020 Debates and Didactics in Hematology and Oncology during a debate between Jean Louise Koff, MD, MS, and James O. Armitage, MD.

The FDA granted an Orphan Drug designation to tolinapant for the treatment of patients with T-cell lymphomas.

The FDA granted a Priority Review to the New Drug Application for oral paclitaxel with encequidar for the treatment of patients with metastatic breast cancer.

Here is a look back at the FDA happenings from the month of August 2020.

In an interview with Targeted Oncology, Andrei Gafita, MD, discussed the recent findings from the international multicenter retrospective analysis of LuPSMA as treatment of patients with metastatic castration-resistant prostate cancer, and how these findings and more clinical trials could lead to the approval of this treatment for patients who have exhausted all other standard treatments.

During a virtual Case Base Peer Perspectives event, Eleni Efstathiou, MD, PhD, a discussed treatment options for a 57-year-old African American man with nonmetastaic castration resistant prostate cancer.

The FDA granted a Fast Track and Orphan Drug designation to VLS-101 for the treatment of patients with mantle cell lymphoma.

The FDA announced draft guidance, which provides recommendations for the design of clinical trials and biological products for product labeling for those with brain metastases regulated by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.

The FDA granted Priority Review to Melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with multiple myeloma that is refractory to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

In an interview with Targeted Oncology, Phillip C. Hoffman, MD, professor of medicine, University of Chicago, and chairperson of ODAC, discussed ODAC operations during the COVID-19 pandemic and the most recently meetings and decisions the committee has made to influence treatments options in oncology.

In an interview with Targeted Oncology, Ruben Mesa, director, MD, discussed the role of JAK inhibitors in early myelofibrosis and other promising treatment options coming down the pipeline.

Targeted Oncology reviews trending news online for the week of August 28, 2020, including recent news from the FDA, updates in oncology, and new information regarding COVID-19.

This is the first report to date that has demonstrated inferior survival outcomes among African American patients with NSCLC harboring an EGFR mutation relative to non-African American patients.

Use of interim positron emission tomography scans to direct patient care has established a new standard treatment approach for patients with limited-stage diffuse large B-cell lymphoma. These findings are from the Intergroup National Clinical Trials Network S1001 study.

The FDA has granted approval to FoundationOne Liquid CDx, a comprehensive liquid biopsy assay for all solid tumors with multiple companion diagnostic indications.

Frontline trastuzumab plus lapatinib and an aromatase inhibitor demonstrated superior progression-free survival compared with the trastuzumab/aromatase inhibitor alone as treatment of patients with HER2-positive, HR-positive metastatic breast cancer.