Gina Columbus

Articles

Giants of Cancer Care Inductee Announced as Next ASCO President

December 19th 2019

Everett E. Vokes, MD, FASCO, who is a Giants of Cancer Care® recipient for Head and Neck Cancer, has been named the next president of ASCO for the 2021 to 2022 term.

FDA Grants Priority Review to UGN-101 for Urothelial Cancer

December 19th 2019

The FDA has granted a priority review designation to a new drug application for UGN-101 for the treatment of patients with low-grade, upper tract urothelial cancer.

FDA Approval Sought for Tazemetostat in Follicular Lymphoma

December 19th 2019

A new drug application has been submitted to the FDA for tazemetostat as a treatment for patients with relapsed/refractory follicular lymphoma, with or without EZH2 activating mutations, who have received ≥2 prior lines of systemic therapy.

FDA Grants Priority Review to Encorafenib/Cetuximab Combo for BRAF+ mCRC

December 19th 2019

The FDA has granted a priority review designation to a supplemental new drug application for the combination of encorafenib and cetuximab as a treatment for patients with advanced BRAF V600E–mutant metastatic colorectal cancer following up to 2 prior lines of therapy.

FDA Panel Supports Tazemetostat for Epithelioid Sarcoma

December 18th 2019

The FDA’s Oncologic Drugs Advisory Committee voted in favor of approving tazemetostat tablets as a treatment for patients with metastatic or locally advanced epithelioid sarcoma that is ineligible for curative surgery.

FDA Grants Ivosidenib Breakthrough Status for Relapsed/Refractory IDH1+ MDS

December 18th 2019

The FDA has granted a breakthrough therapy designation to ivosidenib for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes who harbor IDH1 mutations.

FDA Panel Backs Maintenance Olaparib for Metastatic Pancreatic Cancer

December 17th 2019

The FDA’s Oncologic Drugs Advisory Committee voted 7 to 5 in favor of olaparib tablets for an indication as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma whose disease has not progressed on frontline platinum-based chemotherapy.

FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer

December 17th 2019

The FDA has approved a supplemental new drug application for enzalutamide (Xtandi) for the treatment of patients with metastatic castration-sensitive prostate cancer.

Zanubrutinib Misses Response Endpoint in Waldenstrom Macroglobulinemia, But Trends Toward Clinical Benefit

December 17th 2019

Zanubrutinib did not show a statistically significant improvement in complete response and very good partial response rates compared with ibrutinib in patients with Waldenström macroglobulinemia, missing the primary endpoint of the phase III ASPEN trial.

FDA Approval Sought for Ripretinib for Advanced GIST

December 16th 2019

A new drug application has been submitted to the FDA for ripretinib for use as a treatment for patients with advanced gastrointestinal stromal tumors who have previously received treatment with imatinib, sunitinib, and regorafenib.

Published Entrectinib Data Demonstrate Encouraging Responses in ROS1+ NSCLC

December 16th 2019

Treatment with entrectinib led to an overall response rate of 77% and a median duration of response of 24.6 months in patients with ROS1 fusion–positive non–small cell lung cancer, according to updated findings of a pooled analysis published in Lancet Oncology.

ctDNA and CTCs Potentially Poised to Predict Recurrence for Early TNBC

December 14th 2019

The presence of circulating tumor DNA and circulating tumor cells following neoadjuvant chemotherapy can be an independent predictor of disease recurrence in patients with early triple-negative breast cancer.

Atezolizumab Plus Cobimetinib/Vemurafenib Meets PFS Endpoint in Frontline BRAF V600+ Advanced Melanoma

December 13th 2019

The triplet regimen of atezolizumab, cobimetinib, and vemurafenib was found to improve progression-free survival compared with cobimetinib/vemurafenib plus placebo in patients with previously untreated BRAF V600 mutation–positive advanced melanoma.

Neoadjuvant Atezolizumab Regimen Slightly Improves pCR in TNBC

December 13th 2019

Atezolizumab (Tecentriq) in combination with carboplatin and nab-paclitaxel (Abraxane) did not lead to a statistically significant increase in pathologic complete response (pCR) rate compared with carboplatin/nab-paclitaxel alone in patients with early high-risk and locally advanced triple-negative breast cancer,

FDA Approval Sought for KTE-X19 in Relapsed/Refractory Mantle Cell Lymphoma

December 13th 2019

A biologics license application has been submitted to the FDA for the investigational CAR T-cell therapy KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma.

Adjuvant Pertuzumab Regimen Shows Modest OS Benefit in HER2+ Early Breast Cancer

December 12th 2019

Adjuvant pertuzumab (Perjeta) with trastuzumab (Herceptin) plus chemotherapy showed a 0.9% improvement in overall survival and continued to reduce the risk of disease recurrence in patients with HER2-positive early breast cancer.

Tisagenlecleucel Demonstrates Real-World Clinical Benefit in DLBCL

December 10th 2019

The CAR T-cell therapy tisagenlecleucel (Kymriah) showed similar real-world efficacy and safety findings to that of the JULIET trial in the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma.

Blinatumomab as Post-Reinduction Therapy Improves Survival in Pediatric and AYA B-ALL

December 10th 2019

Blinatumomab (Blincyto) as post-reinduction consolidation therapy before hematopoietic stem cell transplantation improved disease-free survival and overall survival by approximately 20% compared with intensive chemotherapy in pediatric and adolescent and young adult patients with high- or intermediate-risk of first relapse of B-cell acute lymphoblastic leukemia.

Lenalidomide Plus Obinutuzumab Achieves 100% ORR in Rituximab-Refractory Indolent Non-Hodgkin Lymphoma

December 9th 2019

The combination of lenalidomide (Revlimid) and obinutuzumab (Gazyva) elicited a 100% overall response rate in patients with relapsed indolent non-Hodgkin lymphoma that was refractory to rituximab (Rituxan).

Lenalidomide/Rituximab PFS Benefit Maintained in Elderly Subgroup With Indolent Non-Hodgkin Lymphoma

December 9th 2019

The combination of lenalidomide (Revlimid) and rituximab showed a 34% reduction in the risk of disease progression or death compared with rituximab plus placebo in patients ≥70 years old with indolent non-Hodgkin lymphoma, although it was not found to be statistically significant.