Kristi Rosa

Tisagenlecleucel was found to elicit clinically meaningful activity in patients with relapsed/refractory follicular lymphoma, meeting the phase 2 ELARA trial’s primary end point of complete response rate.

The FDA granted an orphan drug designation to the oral investigational modified proprietary tyrosine derivative SM-88 as a treatment for patients with pancreatic cancer.

The FDA has approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

The advent of gene expression assays has provided predictive insight into chemotherapy benefit that can be combined with prognostic information yielded by gene expression profiling to better target patients with breast cancer who are at higher clinical risk for the use of adjuvant chemotherapy.

The FDA has approved atezolizumab (Tecentriq) in combination with cobimetinib (Cotellic) and vemurafenib (Zelboraf) in the treatment of patients with BRAF V600 mutation–positive advanced melanoma.

As new data emerge in the melanoma treatment paradigm, new questions have come to light regarding neoadjuvant/adjuvant strategies, reduced dosing for immunotherapy combinations, and approaches following progression on, or resistance to, PD-1 inhibition.

The FDA has granted breakthrough therapy designation to pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes.

The FDA has accepted 2 supplemental biologics applications for pembrolizumab in patients with triple-negative breast cancer; these are the first US applications for the anti–PD-1 therapy in breast cancer.

A biologics license application has been submitted to the FDA for idecabtagene vicleucel for the treatment of adult patients with relapsed and refractory multiple myeloma.

The FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail test for use as a companion diagnostic for trastuzumab and to detect HER2 mutations in patients with breast cancer.

The FDA has granted a breakthrough therapy designation to MK-6482 for the treatment of patients with von Hippel-Lindau disease–associated renal cell carcinoma who have nonmetastatic tumors of less than 3 centimeters, unless immediate surgery is necessitated.

Hutchinson China Meditech Limited announces that The China National Medical Products Administration granted priority review to the new drug application for the MET inhibitor savolitinib for the treatment of patients with non–small cell lung cancer with MET exon 14 skipping mutations.

The FDA has granted a fast track designation to BDTX-189 for use in adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion mutation who had progressed on previous treatment and have no acceptable options available.

The phase 2 ZENITH20 trial evaluating poziotinib in previously treated patients with non–small cell lung cancer and HER2 exon 20 insertion mutations met its prespecified primary end point.

The European Medicines Agency has granted access to the PRIME initiative for the Specific Peptide Enhanced Affinity Receptor T-cell therapy ADP-A2M4 for the treatment of patients with synovial sarcoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for ibrutinib in combination with rituximab for use in treatment-naïve patients with chronic lymphocytic leukemia.

Although antibody-drug conjugates have yet to receive regulatory approval in the lung cancer space, several emerging agents are showing early promise in clinical trials.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for belantamab mafodotin as a monotherapy in the treatment of adult patients with multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and aCD38-directed monoclonal antibody.

The mortality rate with COVID-19 appears to be higher in patients with cancer—especially those with lung cancer—compared with the general population, and several factors associated with mortality are beginning to emerge.

The FDA has granted a fast track designation for the PKCβ inhibitor enzastaurin for the treatment of patients with newly diagnosed glioblastoma.

The FDA’s Oncologic Drugs Advisory Committee has scheduled a date to review data supporting the biologics license application for remestemcel-L as a treatment for children with steroid-refractory acute graft versus host disease.

The China National Medical Products Administration has accepted a new drug application for ripretinib as a treatment for adult patients with advanced gastrointestinal stromal tumor who have received previous treatment with 3 or more kinase inhibitors, including imatinib.

The situation with the coronavirus-19 pandemic continues to rapidly evolve, but one thing is clear: this is much more than just the common cold.

The FDA has accepted a supplemental new drug application seeking approval for selinexor for the treatment of patients with multiple myeloma following at least 1 previous line of therapy.

Angela DeMichele, MD, MSCE, shares how to utilize available data with CDK4/6 inhibitors in the neoadjuvant and adjuvant settings to optimize outcomes for patients with hormone receptor–positive breast cancer.

Paolo Ghia, MD, PhD, discusses the final results from the phase 3 ASCEND trial with acalabrutinib monotherapy in patients with relapsed/refractory CLL.

The European Medicines Agency has validated a Marketing Authorization Application for the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and grade 3B follicular lymphoma following at least 2 prior therapies.

Anthracycline-based chemotherapy followed by ado-trastuzumab emtansine plus pertuzumab did not show statistically significant or clinically meaningful improvement in invasive disease-free survival in patients with high-risk HER2-positive early breast cancer, missing the primary end point of the phase 3 KAITLIN trial.

The independent data monitoring committee has recommended that Celsion Corporation consider stopping the global, phase 3 OPTIMA trial examining ThermoDox® in combination with radiofrequency ablation for the treatment of patients with hepatocellular carcinoma.

Results from the phase 3 IMagyn050 trial showed that the addition of atezolizumab to bevacizumab, paclitaxel, and carboplatin did not meet the primary end point of progression-free survival for first-line treatment of women with newly diagnosed, advanced ovarian cancer.