Jason M. Broderick

The FDA has granted a priority review designation to pembrolizumab for the treatment of patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high status.

The first 2 patients with COVID-19 have received treatment in a phase II trial exploring the investigational agent leronlimab, a CCR5 antagonist which has been advancing through the pipeline as a treatment for patients with triple-negative breast cancer.

Adding veliparib to frontline induction chemotherapy increased complete and CA-125 responses compared with chemotherapy alone in patients with high-grade serous ovarian cancer, according to an exploratory analysis of the phase III VELIA trial.

The European Commission has approved brigatinib for the first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer.

Positive efficacy data have halted the confirmatory phase III ASCENT study exploring sacituzumab govitecan in patients with metastatic triple-negative breast cancer.

Findings from the pivotal phase II ZUMA-2 trial of KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma were published in the New England Journal of Medicine, as the FDA considers a biologics license application for the CAR T-cell therapy for an approval in this setting.

A Biologics License Application has been filed with the FDA for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma.

The oncology supportive care agent tocilizumab might effectively treat cytokine storm caused by COVID-19 in patients with blood cancers, according to a case study of a patient with multiple myeloma.

The FDA has approved luspatercept for the treatment of anemia in patients with myelodysplastic syndromes.

UGN-102 for intravesical solution induced a 65% complete response rate in patients with low-grade intermediate-risk non-muscle invasive bladder cancer.

The oncology drug ruxolitinib is being explored in the planned phase III RUXCOVID trial as a treatment for cytokine storm in patients with COVID-19.

The anti-DLL4/VEGF bispecific antibody navicixizumab showed promising clinical activity when used in combination with paclitaxel in heavily pretreated patients with platinum-resistant ovarian cancer.

The European Commission has approved the rituximab biosimilar Ruxience for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris

Frontline pembrolizumab significantly improved progression-free survival versus chemotherapy in patients with microsatellite instability–high or mismatch repair deficient unresectable or metastatic colorectal cancer.

The investigational antibody-drug conjugate anetumab ravtansine showed promising antitumor activity in heavily pretreated patients with mesothelin-expressing solid tumors.

OSE-2101 met the primary endpoint in the predefined Step-1 analysis of the phase III Atalante 1 trial in patients with HLA-A2 positive non–small cell lung cancer after failure of anti–PD-1/PD-L1 agents.

The FDA has granted remestemcel-L a priority review designation for the treatment of children with steroid-refractory acute graft versus host disease.

Despite some success stories, most gastrointestinal cancers do not respond to single-agent, or even double-agent, immune checkpoint inhibition, Neeha Zaidi, MD, said in a presentation during the 5th Annual School of Gastrointestinal Oncology™ (SOGO®) conference.

The FDA has granted ME-401 Fast Track Designation for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies.

A new drug application has been submitted to the FDA for tivozanib for the treatment of patients with relapsed/refractory renal cell carcinoma, according to Aveo Oncology, the company developing the VEGFR TKI.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of brentuximab vedotin (Adcetris) for use in combination with chemotherapy for the frontline treatment of adult patients with systemic anaplastic large cell lymphoma.

A biologics license application has been submitted to the FDA for idecabtagene vicleucel (ide-cel; bb2121) for the treatment of adult patients with multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

The European Commission has approved darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease.

Results from the pivotal phase III BELIEVE trial, which supported the FDA approval of luspatercept-aamt for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions, have been published in the New England Journal of Medicine.

Stereotactic ablative radiation reduced disease progression compared with observation in patients with oligometastatic prostate cancer.

A new drug application has been submitted to the Taiwan Food and Drug Administration for avapritinib for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor harboring PDGFRA exon 18 mutations, including PDGFRA D842V mutations, according to CStone Pharmaceuticals, a partner of Blueprint Medicines.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥2 prior therapies.

An independent panel determined that the investigational agent VB-111 met the interim prespecified efficacy criterion in the phase III OVAL study in patients with platinum-resistant ovarian cancer, and that the trial should continue without modification.

Melflufen in continued to show strong clinical activity in patients with triple-class refractory multiple myeloma, according to final topline results from the pivotal phase II HORIZON study.

The FDA has granted a Fast Track Designation to IPI-549 for use in combination with nivolumab for the treatment of patients with advanced urothelial cancer, according to Infinity Pharmaceuticals, Inc., the manufacturer of the PI3K-gamma inhibitor.