Gina Columbus

Articles

FDA Grants Priority Review to Rucaparib for mCRPC

January 16th 2020

The FDA has granted a priority review designation to a supplemental new drug application for rucaparib for the treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castration-resistant prostate cancer.

FDA Grants Priority Review to Frontline Nivolumab/Ipilimumab in Advanced NSCLC

January 15th 2020

The FDA has granted a priority review designation to a supplemental biologics license application for the combination of nivolumab and ipilimumab for the first-line treatment of patients with metastatic or recurrent non–small cell lung cancer that does not have EGFR or ALK genomic tumor aberrations.

Sintilimab Injection Plus Chemo Improves PFS in Frontline Nonsquamous NSCLC

January 14th 2020

The first-line combination of sintilimab injection plus pemetrexed and platinum-based therapy showed a statistically significant improvement in progression-free survival compared with chemotherapy and placebo in patients with advanced or recurrent nonsquamous non–small cell lung cancer who did not harbor EGFR or ALK abnormalities, according to an interim analysis of the phase III ORIENT-11 trial.

FDA Grants Priority Review to Olaparib Plus Bevacizumab as Frontline Maintenance in Ovarian Cancer

January 13th 2020

The FDA has granted a priority review designation to a supplemental new drug application for the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab.

FDA Approves Avapritinib for PDGFRA Exon 18+ GIST

January 10th 2020

The FDA has approved avapritinib for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.

FDA Places Partial Hold on Lacutamab Trial in Advanced T-Cell Lymphoma

January 10th 2020

The FDA has placed a partial clinical hold on the TELLOMAK trial, which is evaluating the efficacy and safety of lacutamab in patients with advanced T-cell lymphoma.

Loncastuximab Tesirine Shows Encouraging ORR in Relapsed/Refractory DLBCL

January 9th 2020

Loncastuximab tesirine demonstrated an overall response rate of 45.5% in patients with relapsed/refractory diffuse large B-cell lymphoma, including those who are difficult to treat.

Pralsetinib Highly Active in RET+ NSCLC, Rolling FDA Submission Started

January 9th 2020

The RET inhibitor pralsetinib demonstrated encouraging and durable responses in patients with RET fusion–positive non–small cell lung cancer who were both treatment-naïve and received prior treatment with platinum-based chemotherapy.

FDA Approves Pembrolizumab for High-Risk NMIBC

January 9th 2020

The FDA has approved pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Pembrolizumab Combo Hits PFS, But Not OS Endpoint in Frontline Small Cell Lung Cancer

January 7th 2020

The combination of pembrolizumab and chemotherapy improved progression-free survival compared with chemotherapy alone as a first-line treatment for patients with extensive-stage small cell lung cancer.

NICE Cites Cost in Deciding Against Atezolizumab for Frontline Advanced Small Cell Lung Cancer

January 7th 2020

The United Kingdom’s National Institute for Health and Care Excellence did not recommend granting marketing authorization to atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the treatment of patients with treatment-naïve extensive-stage small cell lung cancer.

Itacitinib Misses Primary Endpoint in Frontline Acute GVHD

January 7th 2020

The combination of itacitinib and corticosteroids did not induce a statistically significant improvement in overall response rate at day 28 compared with placebo plus corticosteroids in patients with treatment-naïve acute graft-versus-host disease, missing the primary endpoint of the phase III GRAVITAS-301 trial.

Avelumab Improves OS as Frontline Maintenance in Urothelial Carcinoma

January 6th 2020

Frontline maintenance therapy with avelumab plus best supportive care demonstrated a statistically significant improvement in overall survival compared with best supportive care alone in patients with previously untreated locally advanced or metastatic urothelial carcinoma, regardless of PD-L1 expression.

Poziotinib Misses Primary Endpoint in EGFR Exon 20-Mutant NSCLC

January 3rd 2020

Poziotinib did not meet its primary endpoint of overall response rate in patients with previously treated EGFR-mutant non–small cell lung cancer who have exon 20 insertion mutations.

FDA to Review Eflapegrastim for Chemo-Induced Neutropenia

January 2nd 2020

The FDA has accepted a biologics license application to review eflapegrastim for the management of chemotherapy-induced neutropenia.

Frontline Pembrolizumab/Axitinib Approved in Japan for Advanced RCC

December 21st 2019

Japan’s Pharmaceuticals and Medical Devices Agency has approved the combination of pembrolizumab and axitinib for the first-line treatment of patients with radically unresectable or metastatic renal cell carcinoma.

FDA Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer

December 21st 2019

The FDA has granted an accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.

Frontline Pembrolizumab Regimens Receive Japanese Approval in Head and Neck Cancer

December 20th 2019

Japan's Pharmaceuticals and Medical Devices Agency has granted approval to frontline pembrolizumab as monotherapy and in combination with chemotherapy for the treatment of patients with recurrent or distant metastatic head and neck cancer.

FDA Approval Sought for Rituximab Biosimilar

December 20th 2019

A biologics license application has been submitted to the FDA for the rituximab biosimilar ABP 798.

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

December 19th 2019

The European Commission has approved ado-trastuzumab emtansine for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease (breast and/or lymph nodes) following neoadjuvant taxane-based chemotherapy and HER2-targeted therapy.