Jason M. Broderick

Articles

FDA Grants DKN-01 Orphan Drug Status for Gastric/GEJ Cancer

June 12th 2020

The FDA has granted an Orphan Drug designation to DKN-01 for the treatment of patients with gastric cancer or gastroesophageal junction cancer.

FDA Grants Berubicin Orphan Drug Status for Brain Cancer

June 11th 2020

The FDA has granted an orphan drug designation to berubicin for the treatment of patients with malignant gliomas.

FDA Approves Nivolumab for Esophageal Cancer

June 11th 2020

The FDA has approved nivolumab for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.

Pembrolizumab Combo Falls Short in Phase 3 Frontline Urothelial Carcinoma Trial

June 10th 2020

Adding pembrolizumab to chemotherapy did not lead to a statistically significant improvement in overall survival or progression-free survival in patients with advanced or metastatic urothelial carcinoma, according to findings from the phase 3 KEYNOTE-361 trial.

Pembrolizumab Combo Falls Short in Phase 3 Frontline Urothelial Carcinoma Trial

June 10th 2020

Adding pembrolizumab to chemotherapy did not lead to a statistically significant improvement in overall survival or progression-free survival in patients with advanced or metastatic urothelial carcinoma, according to findings from the phase 3 KEYNOTE-361 trial.

FDA Accepts Application for Ropeginterferon Alfa-2b for Polycythemia Vera

June 5th 2020

The FDA has accepted an application for ropeginterferon alfa-2b for use as a treatment for patients with polycythemia vera.

FDA Grants Margetuximab Orphan Drug Status for Gastric Cancer

June 5th 2020

The FDA has granted margetuximab an Orphan Drug designation for the treatment of patients with gastric and gastroesophageal junction cancer.

Subcutaneous Daratumumab Approved in Europe for Myeloma

June 4th 2020

The European Commission has approved subcutaneous formulation of daratumumab for the treatment of patients with multiple myeloma.

Isatuximab Approved in Europe for Relapsed/Refractory Myeloma

June 2nd 2020

The European Commission has approved isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥2 prior therapies.

Melflufen Continues Advance Through Myeloma Pipeline

June 2nd 2020

An update on the phase 3 OCEAN study of melflufen in relapsed/refractory multiple myeloma reported that patients stayed on treatment longer than had been previously estimated.

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