Gina Columbus

Articles

NICE Rejects Pembrolizumab for Urothelial Carcinoma

March 13th 2020

The United Kingdom’s National Institute for Health and Care Excellence has chosen not to recommend pembrolizumab as a treatment for patients with locally advanced or metastatic urothelial carcinoma who have previously received platinum-containing chemotherapy.

FDA Places Partial Hold on Non-Hodgkin Lymphoma Trial

March 11th 2020

The FDA has placed a partial clinical hold on a phase I trial assessing the autologous T-cell therapy ACTR707 in combination with rituximab for patients with CD20-positive, B-cell non-Hodgkin lymphoma due to a safety concern.

FDA Approves Nivolumab/Ipilimumab for Advanced HCC

March 11th 2020

The FDA has granted an accelerated approval to the combination of nivolumab and ipilimumab for the treatment of patients with hepatocellular carcinoma who have received prior therapy with sorafenib.

FDA Grants Breakthrough Designation to JNJ-6372 for EGFR Exon 20-Mutant NSCLC

March 11th 2020

The FDA has granted a breakthrough therapy designation to JNJ-61186372 for the treatment of patients with EGFR-positive metastatic non–small cell lung cancer who harbor exon 20 insertion mutations, and whose disease has progressed on or after platinum-based chemotherapy.

Ixazomib Frontline Triplet Misses PFS Endpoint in Transplant-Ineligible Myeloma

March 10th 2020

The triplet therapy of ixazomib, lenalidomide, and dexamethasone showed an improvement in progression-free survival, but it was not statistically significant, compared with lenalidomide/dexamethasone alone for patients with newly diagnosed multiple myeloma who were ineligible for stem cell transplant.

Frontline Elotuzumab Triplet Misses PFS Endpoint in Multiple Myeloma

March 9th 2020

The addition of elotuzumab to lenalidomide and dexamethasone did not show a statistically significant improvement in progression-free survival compared with lenalidomide/dexamethasone alone in patients with newly diagnosed, previously untreated, transplant-ineligible multiple myeloma.

Durvalumab/Tremelimumab Combo Misses OS Endpoints in Metastatic Bladder Cancer

March 6th 2020

Durvalumab alone did not improve overall survival compared with standard-of-care chemotherapy in patients with unresectable urothelial cancer whose tumors had high levels (≥25%) of PD-L1 expression, missing both primary endpoints of the phase III DANUBE trial.

FDA Reviewing Bevacizumab Biosimilar

March 6th 2020

The FDA has accepted a biologics license application for a proposed biosimilar for bevacizumab.

FDA Grants Breakthrough Device Status to Elecsys GALAD Score for HCC

March 4th 2020

The FDA has granted a breakthrough device designation to the Elecsys GALAD score, an algorithmic score designed to aid in the diagnosis of early-stage hepatocellular carcinoma.

FDA Grants Fast Track Designation to Tipifarnib for T-Cell Lymphomas

March 3rd 2020

The FDA has granted a Fast Track Designation to tipifarnib for the treatment of adult patients with relapsed/refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, and nodal peripheral T-cell lymphoma with T follicular help phenotype.

FDA Approves Isatuximab for Relapsed/Refractory Myeloma

March 3rd 2020

The FDA has approved isatuximab-irfc (Sarclisa) for use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor.

Selinexor Regimen Improves PFS in Relapsed/Refractory Myeloma

March 2nd 2020

Selinexor in combination with bortezomib and low-dose dexamethasone led to a statistically significant increase in progression-free survival compared with bortezomib/dexamethasone alone in patients with multiple myeloma who have received 1 to 3 prior lines of therapy.

FDA Grants Priority Review to Tafasitamab/Lenalidomide Combo for Relapsed/Refractory DLBCL

March 2nd 2020

The FDA has granted a priority review designation to a biologics license application for the combination of tafasitamab and lenalidomide for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.

Pembrolizumab Improves PFS in Relapsed/Refractory Hodgkin Lymphoma

March 2nd 2020

Pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with brentuximab vedotin in adult patients with relapsed/refractory classic Hodgkin lymphoma, meeting one of the dual primary endpoints of the phase III KEYNOTE-204 trial.

Key AE Management Strategies in Place for CAR T-Cell Therapy in Hematologic Cancers

February 29th 2020

With the main toxicities associated with CAR T-cell therapy being cytokine release syndrome and neurotoxicity, a multidisciplinary approach is vital to providing inclusive care to patients receiving this type of treatment.

NICE Recommends Lenalidomide/Rituximab for Follicular Lymphoma

February 28th 2020

The United Kingdom’s National Institute for Health and Care Excellence has recommended the combination of lenalidomide and rituximab as a treatment option for adult patients with grade 1 to 3A previously treated follicular lymphoma.

FDA Grants Breakthrough Designation to Debio 1143 in Frontline Head and Neck Cancer

February 27th 2020

The FDA has granted a breakthrough therapy designation to Debio 1143, an inhibitor of apoptosis protein antagonist, for the treatment of patients with previously untreated, unresectable, locally advanced squamous cell carcinoma of the head and neck in combination with standard cisplatin-based concomitant fractionation chemoradiation therapy

Frontline Maintenance Niraparib Takes Step Toward EU Approval in Ovarian Cancer

February 27th 2020

The European Medicines Agency has validated a Type II Variation for niraparib as a first-line maintenance treatment for patients with advanced ovarian cancer who have responded to platinum-based chemotherapy, regardless of biomarker status.

FDA Panel Narrowly Supports Ramucirumab/Erlotinib Combo in Frontline EGFR+ NSCLC

February 27th 2020

The FDA's Oncologic Drugs Advisory Committee voted 6 to 5 in favor of intravenous ramucirumab injection for use in combination with erlotinib as a frontline treatment for patients with metastatic non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.

FDA Approves Neratinib Combo for HER2+ Breast Cancer

February 26th 2020

The FDA has approved a supplemental new drug application for neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.