Gina Columbus

Articles

FDA Grants Priority Review to Selinexor for Relapsed/Refractory DLBCL

February 20th 2020

The FDA has granted a priority review designation to a supplemental new drug application for selinexor as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma, not otherwise specified, who have received ≥2 prior therapies.

FDA Issues Complete Response Letter for Updated Pembrolizumab Dosing Schedule

February 20th 2020

The FDA has issued a complete response letter to 6 supplemental biologics license applications that would have updated the dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg over 30-minute infusions across multiple indications.

FDA Grants Breakthrough Designation to Frontline Enfortumab Vedotin/Pembrolizumab in Bladder Cancer

February 20th 2020

The FDA has granted a breakthrough therapy designation to the combination of enfortumab vedotin-ejfv and pembrolizumab as a first-line treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy.

FDA Grants Priority Review to Frontline Atezolizumab for Advanced PD-L1-High NSCLC

February 19th 2020

The FDA has granted a priority review designation to a supplemental biologics license application for single-agent atezolizumab as a frontline treatment for patients with advanced nonsquamous or squamous non–small cell lung cancer without EGFR or ALK mutations who have high PD-L1 expression on tumor cells or tumor-infiltrating immune cells, defined as TC3/IC3 wild-type.

Cabozantinib Plus Atezolizumab Active in mCRPC

February 19th 2020

The combination of cabozantinib and atezolizumab demonstrated clinically meaningful activity in patients with metastatic castration-resistant prostate cancer, including those with high-risk clinical features.

Nivolumab/Cabiralizumab Combo Misses PFS Endpoint in Pancreatic Cancer

February 19th 2020

The combination of nivolumab and the investigational CSF-1R inhibitor cabiralizumab with and without chemotherapy did not improve progression-free survival compared with chemotherapy alone in patients with advanced pancreatic cancer, missing the primary endpoint of a phase II trial (NCT03336216).

FDA Grants Priority Review to Lurbinectedin in Small Cell Lung Cancer

February 17th 2020

The FDA has granted a priority review designation to a new drug application for lurbinectedin as a treatment for patients with small cell lung cancer who have progressed following platinum-containing therapy.

Ilixadencel Added to Sunitinib Shows Positive OS Trend in RCC

February 13th 2020

The addition of the off-the-shelf cancer immune primer ilixadencel to sunitinib trended toward a benefit in overall survival compared with sunitinib alone as a first-line treatment for patients with newly diagnosed metastatic renal cell carcinoma.

Frontline Pembrolizumab/Chemo Combo Improves PFS in PD-L1+ Metastatic TNBC

February 12th 2020

The frontline combination of pembrolizumab and chemotherapy significantly improved progression-free survival compared with chemotherapy alone in patients with metastatic triple-negative breast cancer whose tumors expressed PD-L1.

Enzalutamide Improves Survival in Nonmetastatic CRPC

February 12th 2020

Enzalutamide plus androgen deprivation therapy demonstrated a statistically significant improvement in overall survival compared with placebo/ADT in patients with nonmetastatic castration-resistant prostate cancer.

Frontline Enfortumab Vedotin Plus Pembrolizumab Shows Encouraging Data in Advanced Urothelial Cancer

February 11th 2020

Enfortumab vedotin-ejfv combined with pembrolizumab led to an objective response rate of 73% in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for cisplatin-based chemotherapy.

FDA Approves Pemetrexed Injection for Nonsquamous NSCLC and Malignant Pleural Mesothelioma

February 10th 2020

The FDA has granted a final approval to pemetrexed for injection, an alternative to standard pemetrexed, for the treatment of patients with locally advanced or metastatic nonsquamous non–small cell lung cancer and for those with malignant pleural mesothelioma.

FDA Grants Priority Review to KTE-X19 in Mantle Cell Lymphoma

February 10th 2020

The FDA has granted a priority review designation to a biologics license application for the investigational CAR T-cell therapy KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma.

FDA Extends Review Period for Avapritinib in Fourth-Line GIST

February 7th 2020

The FDA has extended the Prescription Drug User Fee Act deadline for a new drug application for avapritinib as a treatment for adult patients with fourth-line gastrointestinal stromal tumor.

Rituximab Biosimilar Nears EU Approval for Oncologic and Other Indications

February 4th 2020

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for the rituximab biosimilar PF-05280586 for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

Belantamab Mafodotin Myeloma Application Fast-Tracked in EU

February 3rd 2020

The European Medicines Agency has validated a Marketing Authorization Application for belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor, and a CD38-directed monoclonal antibody.

Dinutuximab Misses Survival Endpoint in Small Cell Lung Cancer

February 3rd 2020

The addition of dinutuximab injection to irinotecan did not improve overall survival compared with irinotecan or topotecan alone in patients with relapsed/refractory small cell lung cancer, missing the primary endpoint of the phase II/III DISTINCT trial.

EU Application Withdrawn for Frontline Nivolumab/Ipilimumab in NSCLC

February 3rd 2020

Bristol-Myers Squibb has withdrawn its application in the European Union for the frontline combination of nivolumab and ipilimumab as a treatment for patients with advanced non–small cell lung cancer.

Darolutamide Nears EU Approval for Nonmetastatic CRPC

February 1st 2020

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease.

EU Panel Recommends Frontline Venetoclax/Obinutuzumab in CLL

January 31st 2020

The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to the fixed-dose combination of venetoclax and obinutuzumab for the treatment of patients with previously untreated chronic lymphocytic leukemia.