Jason M. Broderick

Articles

FDA Grants Pembrolizumab Priority Review for TMB-High Tumors

April 7th 2020

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.

Leronlimab COVID-19 Trial Treats First Patients

April 7th 2020

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.

Analysis Pinpoints Veliparib Antitumor Activity in Ovarian Cancer

April 6th 2020

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.

Brigatinib Approved in Europe for Frontline ALK+ NSCLC

April 6th 2020

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

Sacituzumab Govitecan Succeeds in Phase III TNBC Trial, as FDA Weighs Approval

April 6th 2020

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

KTE-X19 Pivotal MCL Data Published in NEJM as FDA Weighs Approval

April 4th 2020

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.

FDA Approval Sought for Naxitamab in Neuroblastoma

April 4th 2020

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

Tocilizumab Successfully Treats COVID-19 in Patient With Myeloma

April 4th 2020

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.

FDA Approves Luspatercept for MDS-Associated Anemia

April 4th 2020

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

UGN-102 Active in Non-Muscle Invasive Bladder Cancer

April 3rd 2020

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

Ruxolitinib Phase III Trial Launching for COVID-19 Complications

April 3rd 2020

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.

Navicixizumab Combo Shows Benefit in Heavily Pretreated Ovarian Cancer

April 3rd 2020

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.

Rituximab Biosimilar Ruxience Approved in Europe

April 2nd 2020

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

Pembrolizumab Improves PFS in Frontline MSI-H/dMMR Colorectal Cancer

April 2nd 2020

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

Anetumab Ravtansine Shows Promise in Mesothelin-Expressing Solid Tumors

April 2nd 2020

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

Cancer Vaccine Hits Early Benchmark in NSCLC, But COVID-19 Halts Phase III Trial

April 2nd 2020

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.

FDA Grants Remestemcel-L Priority Review for Pediatric GVHD

April 1st 2020

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

Novel Approaches to Build on Checkpoint Inhibition in GI Cancers

April 1st 2020

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.

FDA Grants ME-401 Fast Track Designation for Follicular Lymphoma

April 1st 2020

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.

FDA Approval Sought for Tivozanib in Relapsed/Refractory Renal Cell Carcinoma

April 1st 2020

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.