Gina Columbus

Articles

Tucatinib Takes Step Toward EU Approval in HER2+ Breast Cancer

January 31st 2020

The European Medicines Agency has validated a Marketing Authorization Application for tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have received ≥2 prior anti-HER2 treatment regimens.

FDA Grants Breakthrough Designation to APR-246/Azacitidine Combo in TP53-Mutant MDS

January 31st 2020

The FDA has granted a breakthrough therapy designation to the combination of APR-246 and azacitidine for the treatment of patients with myelodysplastic syndromes with a susceptible TP53 mutation.

Orthopedic Oncologists Essential to Optimal QoL for Patients With Metastatic Bone Disease

January 30th 2020

R. Lor Randall, MD, discusses the referral challenges for orthopedic oncologists and the importance of improving quality of life for patients with metastatic bone disease.

Darolutamide Improves Survival in Nonmetastatic CRPC

January 30th 2020

Darolutamide plus androgen deprivation therapy (ADT) led to a significant improvement in overall survival (OS) compared with placebo and ADT in patients with nonmetastatic castration-resistant prostate cancer, according to results from a preplanned final OS analysis of the phase III ARAMIS trial.

Japanese Approval Sought for Cabozantinib in Advanced HCC

January 30th 2020

A new drug application has been filed with the Japanese Ministry of Health, Labor and Welfare for manufacturing and marketing approval of cabozantinib for the treatment of patients with unresectable hepatocellular carcinoma following progression on prior systemic therapy.

KTE-X19 MCL Application Enters EU Regulatory Pipeline

January 30th 2020

The European Medicines Agency has validated and is now evaluating a Marketing Authorization Application for the CAR T-cell therapy KTE-X19 for the treatment of adult patients with relapsed/refractory mantle cell lymphoma.

FDA Grants Priority Review to Selpercatinib for RET Fusion+ NSCLC and Thyroid Cancers

January 29th 2020

The FDA has granted a priority review designation to a new drug application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion–positive non–small cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion–positive thyroid cancer.

FDA Approval Sought for Frontline Atezolizumab Plus Bevacizumab in HCC

January 27th 2020

A supplemental biologics license application has been submitted to the FDA for the combination of atezolizumab and bevacizumab for the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.

Adjuvant Atezolizumab Misses DFS Endpoint in Muscle-Invasive Bladder Cancer

January 24th 2020

Adjuvant treatment with atezolizumab did not significantly improve disease-free survival compared with observation in patients with muscle-invasive bladder cancer, missing the primary endpoint of the phase III IMvigor010 trial.

FDA Approves Tazemetostat for Epithelioid Sarcoma

January 24th 2020

The FDA has granted an accelerated approval to tazemetostat for the treatment of adult and pediatric patients aged ≥16 years old with metastatic or locally advanced epithelioid sarcoma that is not eligible for complete resection.

Adjuvant T-DM1 Approved in China for HER2+ Early Breast Cancer

January 24th 2020

China’s State Administration of Drug Administration has approved ado-trastuzumab emtansine for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual disease following a neoadjuvant trastuzumab-based regimen.

NICE Recommends Against Frontline Osimertinib in EGFR-Mutant NSCLC

January 23rd 2020

The United Kingdom’s National Institute for Health and Care Excellence will not recommend osimertinib as a frontline treatment for patients with locally advanced or metastatic EGFR-mutant non–small cell lung cancer.

Blood-Based Assay Identifies Hard-to-Detect Gastrointestinal Cancers

January 22nd 2020

A DNA methylation-based cell-free DNA assay demonstrated high specificity and accurate localization of cancers to specific regions of the gastrointestinal tract.

Frontline Daratumumab Regimen Approved in EU for Transplant-Eligible Myeloma

January 22nd 2020

The European Commission has granted marketing authorization for daratumumab in combination with bortezomib, thalidomide, and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

Polatuzumab Vedotin Approved in Europe for Relapsed/Refractory DLBCL

January 22nd 2020

The European Commission has granted a conditional marketing authorization to polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma who are ineligible for hematopoietic stem cell transplant.

Surufatinib Improves PFS in Advanced Pancreatic Neuroendocrine Tumors

January 22nd 2020

Surufatinib improved progression-free survival compared with placebo in patients with low- or intermediate-grade advanced pancreatic neuroendocrine tumors for whom there is no effective therapy.

FDA Grants Durvalumab Plus Tremelimumab Orphan Drug Status in HCC

January 22nd 2020

The FDA has granted an orphan drug designation to durvalumab and tremelimumab for the treatment of patients with hepatocellular carcinoma.

FDA Grants Priority Review to Belantamab Mafodotin for Relapsed/Refractory Myeloma

January 21st 2020

The FDA has granted a priority review designation to a biologics license application for belantamab mafodotin as a treatment for patients with relapsed/refractory multiple myeloma who received prior therapy with an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

Tislelizumab Frontline Combos Improve PFS in Squamous NSCLC

January 21st 2020

The anti–PD-1 agent tislelizumab (BGB-A317) in combination with chemotherapy improved progression-free survival compared with chemotherapy alone as a first-line treatment for patients with advanced squamous non–small cell lung cancer.

FDA Grants Priority Review to Olaparib for HRR-Mutant mCRPC

January 21st 2020

The FDA has granted a priority review designation to a supplemental new drug application for olaparib (Lynparza) for the treatment of patients with metastatic castration-resistant prostate cancer who have deleterious or suspected deleterious or somatic homologous recombination repair gene mutations, and who have also progressed on prior therapy with a new hormonal agent.