Gina Columbus

Articles

Brigatinib Maintains PFS Benefit in Frontline ALK+ NSCLC at Long-Term Follow-Up

November 25th 2019

Treatment with brigatinib demonstrated a 57% reduction in the risk of disease progression or death compared with crizotinib in patients with advanced ALK-positive non–small cell lung cancer who had not received a prior ALK inhibitor.

Nivolumab/Ipilimumab Misses Coprimary Endpoint in Adjuvant Melanoma Trial

November 20th 2019

The combination of nivolumab and ipilimumab did not show a statistically significant improvement in recurrence-free survival compared with single-agent nivolumab as an adjuvant treatment for patients who have had complete surgical removal of stage IIIB/C/D or stage IV melanoma and whose tumors expressed PD-L1

Pembrolizumab Regimens Approved in EU for Frontline PD-L1+ HNSCC

November 20th 2019

The European Commission has approved pembrolizumab as a monotherapy or in combination with platinum and 5-FU chemotherapy for the frontline treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma and PD-L1 expression (composite positive score ≥1) on their tumors.

Frontline Daratumumab Triplet Approved in EU for Transplant-Ineligible Myeloma

November 20th 2019

The European Commission has approved the triplet regimen of daratumumab with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Relugolix Elicits High Response Rate in Advanced Prostate Cancer

November 19th 2019

Treatment with relugolix achieved a high rate of sustained testosterone suppression to castrate levels in patients with androgen-sensitive advanced prostate cancer, meeting the primary endpoint of the phase III HERO trial.

FDA Accepts Application for Bevacizumab Biosimilar

November 19th 2019

The FDA has accepted a biologics license application for the proposed bevacizumab biosimilar SB8.

Vemurafenib/Cobimetinib Shows Long-Term OS Benefit in BRAF+ Melanoma

November 19th 2019

The combination of vemurafenib and cobimetinib led to a 5-year overall survival rate of nearly 40% in patients with BRAF V600E–mutant metastatic melanoma who had not received prior therapy with a BRAF inhibitor.

Fostamatinib Slated for EU Approval in Chronic ITP

November 16th 2019

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for a Marketing Authorization Application of fostamatinib disodium hexahydrate for the treatment of adult patients with chronic immune thrombocytopenia who are refractory to other treatments.

Lenalidomide/Rituximab Combo Nears EU Approval for Follicular Lymphoma

November 15th 2019

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the combination of lenalidomide and rituximab for the treatment of adult patients with grade 1 to 3a previously treated follicular lymphoma.

FDA Approves Zanubrutinib for Relapsed/Refractory MCL

November 15th 2019

The FDA has granted an accelerated approval to zanubrutinib capsules for the treatment of adult patients with mantle cell lymphoma who have received ≥1 prior therapy.

Secondary Cytoreduction Does Not Improve Survival in Recurrent Ovarian Cancer

November 15th 2019

Secondary cytoreduction followed by chemotherapy was not found to improve overall survival compared with chemotherapy alone in patients with platinum-sensitive recurrent ovarian cancer.

KD025 Hits High Response Rate in Chronic GVHD

November 12th 2019

Treatment with the selective ROCK2 inhibitor KD025 led to statistically significant overall response rates in patients with chronic graft-versus-host disease who have received ≥2 prior lines of systemic therapy.

Varlitinib Misses PFS, ORR Endpoints in Biliary Tract Cancer

November 12th 2019

Varlitinib combined with capecitabine did not improve progression-free survival nor overall response rate compared with capecitabine/placebo as a second-line treatment in patients with biliary tract cancer.

FDA Grants Priority Review to Nivolumab/Ipilimumab in Advanced HCC

November 11th 2019

The FDA has granted a priority review designation to a supplemental biologics license application for the combination of nivolumab and ipilimumab for the treatment of patients with advanced hepatocellular carcinoma who received prior therapy with sorafenib.

FDA Approves Luspatercept for Beta Thalassemia–Associated Anemia

November 8th 2019

The FDA has approved luspatercept-aamt (Reblozyl) for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions.

FDA Approval Sought for Ibrutinib/Rituximab in Frontline CLL/SLL

November 8th 2019

A supplemental new drug application has been submitted to the FDA for ibrutinib (Imbruvica) for use in combination with rituximab (Rituxan) for the first-line treatment of patients ≤70 years old with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Ixazomib Improves PFS as Frontline Maintenance in Multiple Myeloma

November 7th 2019

Ixazomib significantly improved progression-free survival as a first-line maintenance therapy compared with placebo in adult patients with multiple myeloma who have not undergone stem cell transplantation, meeting the primary endpoint of the phase III TOURMALINE-MM4 study.

INO-5401/INO-9012 Plus Cemiplimab Hits High 6-Month PFS Rate in Newly Diagnosed GBM

November 6th 2019

The combination of INO-5401 and INO-9012 with cemiplimab, plus chemoradiation, demonstrated promising 6-month progression-free survival rates in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase methylated or unmethylated.

FDA Approves Sandoz's Pegfilgrastim Biosimilar

November 5th 2019

The FDA has approved the pegfilgrastim biosimilar LA-EP2006 (pegfilgrastim-bmez; Ziextenzo) as a treatment to decrease the incidence of infection, exhibited from febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer therapy that is associated with a clinically significant incidence of febrile neutropenia.

PEGPH20 Misses OS Endpoint in Metastatic Pancreatic Cancer

November 4th 2019

The investigational agent pegvorhyaluronidase alfa in combination with gemcitabine and nab-paclitaxel did not show an improvement in overall survival compared with gemcitabine and nab-paclitaxel alone in patients with metastatic pancreatic cancer, missing the primary endpoint of the phase III HALO-109-301 trial.