Gina Columbus

Articles

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.

FDA Panel Supports Belantamab Mafodotin for Relapsed/Refractory Myeloma

July 14th 2020

The FDA’s Oncologic Drugs Advisory Committee voted 12 to 0 in favor of approving belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma who have previously received at least 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and a CD38-directed antibody.

Olaparib Approved in Europe for BRCA+ Pancreatic Cancer

July 8th 2020

The European Commission has approved single-agent olaparib as a maintenance treatment for adult patients with germline BRCA1/2-mutant metastatic pancreatic adenocarcinoma who have not progressed after a minimum of 16 weeks of a frontline platinum-based chemotherapy regimen.

Phase 3 Pracinostat Trial Discontinued in Newly Diagnosed AML

July 2nd 2020

Patient recruitment has been discontinued to an interim futility analysis of a phase 3 trial evaluating pracinostat in combination with azacitidine in patients with acute myeloid leukemia demonstrated that it is unlikely to meet the primary end point of overall survival compared with a control arm.

St. Jude Launches Pediatric Global COVID-19 Observatory and Resource Center

June 28th 2020

Following the arrival of the coronavirus disease 2019 pandemic, St. Jude Children's Research Hospital launched the first Global COVID-19 Observatory and Resource Center for Childhood Cancer.

Neoadjuvant Nivolumab/Ipilimumab Improves RFS in Stage III Macroscopic Melanoma

June 24th 2020

The neoadjuvant combination of nivolumab and ipilimumab continues to demonstrate a benefit in RFS compared with the combination given in the adjuvant setting in patients with stage III macroscopic melanoma.

Tiragolumab/Atezolizumab Shows Early First-in-Human Efficacy in Frontline PD-L1+ NSCLC

June 24th 2020

Tiragolumab in combination with atezolizumab (Tecentriq) demonstrated early clinical activity and was found to be well tolerated in patients with advanced solid tumors, including those with metastatic non–small cell lung cancer who were PD-L1 positive and had not received prior checkpoint inhibition.

Atezolizumab Regimen Improves OS in Frontline Extensive-Stage Small Cell Lung Cancer, Regardless of Biomarker Status

June 22nd 2020

The combination of atezolizumab plus carboplatin/etoposide continued to demonstrate an improvement in overall survival versus chemotherapy alone as a frontline treatment for patients with extensive-stage small cell lung cancer.

FDA Grants Priority Review to Relugolix for Advanced Prostate Cancer

June 22nd 2020

The FDA has granted a priority review designation to a new drug application for relugolix as a treatment for patients with advanced prostate cancer.

Pembrolizumab Approved in China for Second-Line PD-L1+ Esophageal Cancer

June 22nd 2020

The National Medical Products Administration in China has approved pembrolizumab for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 as determined by an approved test, following disease progression on 1 prior line of systemic therapy.

iNEST/Atezolizumab Combo Induces Neoantigen-Specific T-Cell Responses in Advanced Solid Tumors

June 22nd 2020

The addition of the individualized neoantigen specific immunotherapy RO7198457 to atezolizumab induced neoantigen-specific T-cell responses, and was found to be well tolerated in patients with advanced solid malignancies.