Gina Columbus


FDA Approval Sought for Frontline Cabozantinib/Nivolumab Combo in Advanced RCC

August 24th 2020

A supplemental new drug application has been submitted to the FDA for the combination of cabozantinib and nivolumab as a treatment for patients with advanced renal cell carcinoma.

FDA Grants Umbralisib Priority Review for Previously Treated MZL

August 13th 2020

The FDA has granted a priority review designation to a new drug application for umbralisib for the treatment of patients with previously treated marginal zone lymphoma who have received at least 1 prior anti-CD20–based treatment.

Sintilimab/Pemetrexed Regimen Significantly Improves PFS in Advanced NSCLC

August 8th 2020

Sintilimab injection plus pemetrexed and platinum-based therapy led to a statistically significant improvement in progression-free survival compared with chemotherapy alone as a first-line treatment for patients with locally advanced or metastatic nonsquamous non–small cell lung cancer.

FDA Approves Belantamab Mafodotin-blmf for Relapsed/Refractory Multiple Myeloma

August 6th 2020

The FDA has approved belantamab mafodotin-blmf (Blenrep) as a treatment for patients with relapsed/refractory multiple myeloma who have received 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

Entrectinib Approved in Europe for NTRK+ Tumors and ROS1+ NSCLC

August 3rd 2020

The European Commission has approved entrectinib for the treatment of adult and pediatric patients ≥12 years of age with solid tumors that harbor an NTRK fusion, as well as for the treatment of adult patients with ROS1-positive, advanced non—small cell lung cancer not previously treated with ROS1 inhibitors.

FDA Grants Adjuvant Osimertinib Breakthrough Status in Early-Stage EGFR+ NSCLC

July 30th 2020

The FDA has granted a breakthrough therapy designation to osimertinib for the adjuvant treatment of patients with stage IB, II, and IIIA EGFR-mutated non–small cell lung cancer following complete resection with curative intent.

FDA Approves Brexucabtagene Autoleucel for Relapsed/Refractory MCL

July 24th 2020

The FDA has approved the CAR T-cell therapy brexucabtagene autoleucel (Tecartus; formerly KTE-X19) as a treatment for adult patients with relapsed/refractory mantle cell lymphoma.

Adjuvant Osimertinib Possesses Potential to Revolutionize NSCLC Treatment, But Longer Follow-Up Needed

July 23rd 2020

The disease-free survival benefit observed with the third-generation EGFR TKI osimertinib as an adjuvant treatment in patients with EGFR-mutant non–small cell lung cancer in the phase 3 ADAURA trial is striking.

Ruxolitinib Improves ORR in Steroid-Refractory, Dependent Chronic GVHD

July 23rd 2020

Ruxolitinib was found to demonstrate a superior objective response rate at 24 weeks compared with best available therapy in patients with steroid-refractory or steroid-dependent chronic graft-versus-host-disease, meeting the primary end point of the phase 3 REACH3 trial.

Metastatic HER2+ Breast Cancer Treatment Must Move to Personalized Approach

July 17th 2020

The optimal sequence of therapies for patients with metastatic HER2-positive breast cancer must be an individualized one, and should be dependent on the presence and/or level of central nervous system disease.