The FDA has granted a priority review to pralsetinib for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer as well as for patients with RET fusion–positive thyroid cancer.
Lisa Astor
Lisa Astor is the Associate Editorial Director for Targeted Oncology. Astor received her Bachelor of Arts in English Literature from New York University.
Articles by Lisa Astor
The FDA has approved pralsetinib for the treatment of adult patients with metastatic RET fusion–positive non–small cell lung cancer, as detected by an FDA-approved test.
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.
Standard treatment for accelerated or blast phase myeloproliferative neoplasms consists of hypomethylating agents or intensive induction chemotherapy and transplant. However, newer studies have suggested that accelerated or blast phase MPNs, such as acute myeloid leukemia, can be treated with molecularly driven targeted therapies.
The FDA has granted a fast track designation to PBCAR0191, a CD19-directed allogeneic chimeric antigen receptor T-cell therapy, for the treatment of patients with advanced B-cell precursor acute lymphoblastic leukemia.
"Brain metastases harbor distinct clinically actionable genetic alterations compared to their primary tumors and extracranial sites."
Quantification of circulating tumor cells in cerebrospinal fluid can be used to predict survival outcomes in patients with newly diagnosed leptomeningeal disease, according to the results of a retrospective analysis presented during the Society of Neuro-Oncology’s 2020 Virtual Conference on Brain Metastases .
The FDA has accepted a New Drug Application for umbralisib as treatment of patients with previously treated marginal zone lymphoma who have received at least 1 prior regimen with anti-CD20 therapy and for patients with follicular lymphoma who have received at least 2 prior systemic therapies.
The FDA has granted a fast track designation to a novel antibody-drug conjugate for the treatment of patients with platinum-resistant high-grade serous ovarian cancer who have received up to 3 prior lines of systemic therapy, or for patients who previously received 4 lines of systemic therapy regardless of their platinum status.
Sintilimab in combination with platinum and pemetrexed chemotherapy as frontline treatment of patients with locally advanced or metastatic nonsquamous non–small cell lung cancer improved survival and responses with durable responses observed, according to findings from the ORIENT-11 trial.
In an interview with Targeted Oncology, Salles, explained the unmet needs in DLBCL that may be filled by this new option in the treatment armamentarium and the findings that led to the approval of the combination.
The FDA has approved the Guardant360 CDx liquid biopsy for tumor mutation profiling in patients with any solid malignant neoplasm. This represents the first liquid biopsy companion that is FDA-approved for comprehensive tumor mutation profiling across all solid tumors.
Updated findings from phase 3 APOLLO show an improvement in progression-free survival with daratumumabe plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone alone.
The FDA has approved tafasitamab-cxix in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specific, including DLBCL arising from low-grade lymphoma, and patients who are not eligible for autologous stem cell transplant.
Axicabtagene ciloleucel demonstrated a similar overall response rate in both the trial and non-trial settings as treatment of patients with relapsed or refractory large B-cell lymphoma.
The FDA has approved the Ventana HER2 Dual ISH DNA Probe Cocktail assay as a companion diagnostic for trastuzumab and for the detection of the HER2 biomarker in patients with breast cancer.
A Biologics License Application has been submitted to the FDA for the use of idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma
The FDA has granted an Orphan Drug designation to cobomarsen for the treatment of patients with T-cell lymphoma, according to an announcement from miRagen Therapeutics.
The FDA has approved brexucabtagene autoleucel for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
A pivotal phase 3 trial has been initiated to explore the combination of cabozantinib and atezolizumab for the treatment of patients with inoperable, locally advanced or metastatic renal cell carcinoma who progressed during or after treatment with an immune checkpoint inhibitor immediately following initial therapy.
The risk of relapse or death was reduced by 61% with sorafenib maintenance compared with placebo following allogeneic hematopoietic stem cell transplantation in patients with FLT3-ITD–positive acute myeloid leukemia.
The FDA has issued a complete response letter in regard to the applications for potential accelerated approval of pembrolizumab in combination with lenvatinib as treatment of patients with previously untreated, unresectable hepatocellular carcinoma.
Long-term follow-up results from the study were presented in a poster at the virtual 2020 European Society of Medical Oncology World Congress on Gastrointestinal Cancer meeting.
"Patients with unresectable or metastatic MSI-H colorectal cancer have historically faced poor outcomes, and until today, chemotherapy-containing regimens were the only FDA-approved first-line treatment options."
If validated, the investigators believe that this non-invasive test could help detect renal cell carcinoma earlier on, thereby reducing the mortality of the disease.
"As the first FDA-approved therapy to treat this debilitating disease, today’s action is an important step in finding treatment options for patients living with tumor-induced osteomalacia whose tumor cannot be found or removed."
Selinexor is now the only single-agent, oral therapy approved for the treatment of patients with R/R DLBCL, and the only nuclear export inhibitor approved by the FDA for use in 2 hematologic malignancies, multiple myeloma and DLBCL.
“[This] report on the diagnosis of blood cancers in the US/Mexico border inure the different frequency of leukemia subtypes and their outcomes, highlighting important health disparities due to different access to diagnosis and care due to a series of factors."
“The early results of the IPATential150 study are encouraging in our ongoing mission to develop new treatment options for people with advanced prostate cancer.”