Nichole Tucker

The FDA has accepted a Biologics License Application for narsoplimab and granted it Priority Review for use as treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

In an interview with Targeted Oncology, Yelena Y. Janjigian, MD, provided important highlights from the DESTINY-Gastric01 trial and explained the overall impact of the FDA approval of trastuzumab deruxtecan for oncologists treating patients with HER2-positive advanced gastric cancer or GEJ cancers.

The FDA has granted accelerated approval to the subcutaneous formulation of daratumumab with hyaluronidase-fihj as treatment of patients with light chain amyloidosis.

Treatment with the multi-target tyrosine kinase inhibitor anlotinib led to a significant improvement in progression-free survival along with a tolerable and manageable safety profile in Chinese patients with refractory metastatic colorectal cancer. according to results from the phase 3 ALTER0703 trial.

The FDA granted approval to the antineoplastic tyrosine kinase inhibitor, crizotinib, as treatment of pediatric patients 1 year of age and older and young adults with ALK alteration-positive relapsed or refractory systemic anaplastic large cell lymphoma.

The investigational, potent, oral CDK9 inhibitor, zotiraciclib in combination with temozolomide, demonstrated early improvement in progression-free survival as treatment of patients with recurrent high-grade gliomas, meeting the primary end point of the phase 1B 17-C-0009 trial clinical trial.

Anti-CD19 chimeric antigen receptor T-cell therapy with tisagenlecleucel has shown efficacy for the treatment of patients with extensively treated and refractory follicular lymphoma, according to preliminary phase 2 data from the ELARA clinical trial.

The FDA has granted an Orphan Drug Designation to the B-cell maturation antigen BCMA-targeting tri-specific T cell activating recombinant protein construct, HPN217 for the treatment of patients with multiple myeloma.

Twenty-four or more cycles of fedratinib was well-tolerated in patients with intermediate- or high-risk myelofibrosis treated in either the phase 1/2 TED12015 study or the phase 1 TED12037 study. The long-term safety and tolerability results of fedratinib.

The sustainability of efficacy and safety with frontline ibrutinib-based therapy used to treat patients with chronic lymphocytic leukemia who have TP53 aberrations was demonstrated, according to 4-year follow-up result of a pooled analysis.

Patients with ROS1-positive non–small cell lung cancer who have resistance to the ROS1 and ALK inhibitor crizotinib had intracranial and systemic responses to brigatinib, according to findings from a small cohort of patients.

The first patient with newly diagnosed glioblastoma multiforme has been dosed with the first-in-class small molecule enzastaurin in combination with temozolomide and radiotherapy in the phase 3 ENGAGE clinical trial with an aim of determining the overall survival outcome of the drug in this patient population.

The FDA has updated the Prescribing Information for the approved agent darolutamide to include improvement in overall survival in patients with non-metastatic castration-resistant prostate cancer, as well as other secondary end point data, from the phase 3 ARAMIS clinical trial.

The FDA has granted a Fast Track designation to zenocutuzumab as a potential treatment option for patients with metastatic solid tumors harboring NRG1 gene fusions that have progressed on standard of care therapy.

Rituximab added to standard anthracycline-based chemotherapy demonstrated significant improvements in progression-free survival as well as overall survival as treatment of patients with follicular lymphoma, according to 35-year follow-up results of patients treated through the Nebraska Lymphoma Study Group.

Eganelisib, an investigational PI3K-gamma inhibitor in combination with nivolumab, demonstrated promising efficacy compared with nivolumab alone as treatment of platinum-refractory, immunotherapy naïve patients with advanced metastatic urothelial cancer, according to updated findings from the phase 2 MARIO-275 clinical trial.

The investigational selective JAK1 inhibitor, DZD4205, led to anti-tumor activity when given as treatment of patients with relapsed or refractory peripheral T-cell lymphoma , according to results from the phase 1/2 JACKPOT8 clinical trial.

VGX-3100, a therapeutic DNA vaccine, achieved a 25% reduction or more reduction in HPV-16/18-associated vulvar high-grade squamous intraepithelial lesion in 63% of patients at 6 months after treatment with the agent, according to findings from an open-label phase 2 clinical trial.

Pazopanib, a tyrosine kinase inhibitor, is active and well-tolerated in patients with poor-risk metastatic clear cell renal cell carcinoma with no new safety signal observed, according to results from the phase 4 FLIPPER clinical trial.

Treatment with the combination of eprenetapopt and azacitidine did not improve complete responses in patients with TP53-mutant myelodysplastic syndromes.

Treatment with telaglenastat in combination with cabozantinib did not improve progression-free survival in patients with advanced or metastatic renal cell carcinoma when compared with cabozantinib alone, missing the primary end point of the phase 2 CANTANA clinical trial.

The FDA has granted an Orphan Drug Designation to annamycin for the treatment of patients with soft tissue sarcomas.

During a debate at the 27th Annual Prostate Cancer Foundation Virtual Scientific Retreat, Daniel Spratt, MD, debated Daniel Lin, MD, on the subject of genomic classifiers in prostate cancer.

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

In patients with bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancerwith high-risk carcinoma in situ disease, the combination of intravesical BCG and N-803 demonstrated efficacy with a tolerable safety profile, according to findings from the pivotal phase 2/3 QUILT 3.032 study.

Cabozantinib demonstrated significant improvement in progression-free survival in patients with radioiodine-refractory differentiated thyroid cancer who have progressed after up to 2 prior vascular endothelial growth factor receptor-targeted therapies compared with placebo, meeting the primary end point of the pivotal phase 3 COSMIC-311 clinical trial.

A review by an Independent Data Monitoring Committee determined that combination of gilteritinib plus azacitidine would not likely improve overall survival compared with azacitidine alone in patients newly diagnosed FLT3-positive acute myeloid leukemia who were ineligible for intensive induction chemotherapy, missing the primary end point of the phase 3 LACEWING clinical trial.

Treatment with rucaparib led to an improvement in investigator-assessed progression-free survival compared with chemotherapy in patients with relapsed ovarian cancer with a BRCA mutation who have received 2 or more prior lines of chemotherapy, meeting the primary end point of the phase 3 ARIEL4 clinical trial.

The FDA granted approval to rituximab-arrx, a biosimilar to rituximab as treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

A New Drug Application was submitted to the FDA seeking approval of the investigational KRAS G12C inhibitor sotorasib as treatment of patients with KRAS G12C-mutated locally advanced or metastatic non–small cell lung cancer, as determined by an FDA-approved test, following at least 1 prior systemic therapy.