News

Danielle Hammond, MD, discusses prognostic factors indicating therapy success for patients with acute myeloid leukemia treated with a combination of venetoclax (Venclexta) and either decitabine or azacitadine.

Florida Cancer Specialists & Research Institute has appointed a new medical director of the Clinical Research Program, Gustavo Fonseca, MD, FACP.

Xiuning Le, MD, PhD, discusses the limited treatment options available for patients with non–small cell lung cancer and an EGFR exon 20 mutation.

According to a retrospective analysis presented during the 2021 European Lung Cancer Congress, earlier diagnosis and biomarker testing should be more widely implemented to identify patients with EGFR-positive non–small lung cancer who may benefit for EGFR inhibition.

Schlafen-11 expression may serve as a predictive biomarker for response to select treatments in patients with small cell lung cancer.

Both the combination of nivolumab and chemotherapy and nivolumab plus ipilimumab showed a statistically significant and clinically meaningful survival benefit over chemotherapy alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, regardless of PD-L1 expression.

Treatment with pembrolizumab led to improvement in disease-free survival in patients with renal cell carcinoma following nephrectomy or following nephrectomy and resection of metastatic lesions, meeting the primary end point of the pivotal phase 3 KEYNOTE-564 trial.

Physicians published a new analysis that challenges the FDA approval of pembrolizumab for patients with treatment-refractory cancers and a high tumor mutational burden.

A Fast Track designation was granted by the FDA to the soluble LAG-3 protein, eftilagimod alpha for the frontline treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.

While the treatment of relapsed or refractory Hodgkin lymphoma has seen novel approaches in recent years improving outcomes for many patients, high-risk patients develop progressive disease and have limited treatment options.

The FDA granted a regular approval to sacituzumab govitecan for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The FDA has approved a higher dose of cetuximab for the treatmen of patients with KRAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck.

The FDA has issued a letter to the developer of the immunotherapy vaccine, ERC1671, recommending that the phase 2 clinical trial of ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, and cyclophosphamide for the treatment of glioblastoma be terminated.

Robert Rifkin, MD, FACP, a hematology oncologist at the Rocky Mountain Cancer Centers, discusses the need for novel treatment options in the relapsed or refractory multiple myeloma population.

TPX-0046, a next-generation RET inhibitor demonstrated preliminary clinical activity in patients with RET-driven cancers who were treated in the phase 1/2 SWORD-1 clinical trial.

Gerardo Umanzor, MD, explains the potential benefits of oral paclitaxel and encequidar compared with the intravenous formulation for the treatment of metastatic breast cancer during the coronavirus disease 2019 pandemic.

The FDA has administered a Breakthrough Device Designation to ProSense, a liquid-nitrogen based cryoablation system that allows for minimally invasive breast cancer treatment, for the treatment of T1 invasive breast cancer and/or patients not suitable for surgical alternative for breast cancer.

In an interview with Targeted Oncology, Axel Grothey, MD, discussed how HER2 has become an actionable target for gastrointestinal cancers and potential HER2-targeted treatments in the field as well as other interesting studies from the role trastuzumab plays in the space.

In an interview with Targeted Oncology, Thomas Hutson, DO, PharmD, reviewed findings from the CLEAR study and how these data are set to re-shape the treatment landscape of advanced renal cell carcinoma.

A supplemental biologics license application for brexucabtagene autoleucel for the treatment of adult patients with relapsed or refractory B-cell precursors acute lymphoblastic leukemia.

A proprietary noninvasive test designed to detect pancreatic cancer has been granted breakthrough device designation by the FDA for patients with new-onset diabetes.

Surgical oncology expertise has been expanded to local communities in North Texas after physicians from Texas Colon & Rectal Specialists, a large colorectal cancer practice in North Texas, have joined Texas Oncology, increasing The US Oncology Network’s reach.

The phase 3 ARMADA 2000 trial, which aims to determine the efficacy and safety of devimistat in combination with high-dose cytarabine and mitoxantrone compared to controls for older patients with relapsed or refractory acute myeloid leukemia, has crossed the enrollment of 150 participants.

The standard dose of lenvatinib, 18 mg per day, demonstrated an improved health-related quality of life and a longer time to deterioration over a lower starting dose of lenvatinib, 14 mg per day, in patients with renal cell carcinoma, according to secondary results from a phase 2 trial.

A New Drug Application has been submitted to the FDA for the combination of plinabulin and granylocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

A rolling submission of a New Drug Application has been completed for pacritinib which is seeking FDA approval as a treatment for patients with myelofibrosis who have severe thrombocytopenia.

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

The FDA has granted Breakthrough Therapy Designation to futibatinib, a covalently binding FGFR inhibitor for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions.

In an interview with Targeted Oncology, Curtis Lachowiez, MD, discussed the findings from the study of venetoclax added to the FLAG-ID regimen for the treatment of patients with secondary or R/R AML.

The FDA has granted approval to the combination of isatuximab added to carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.