Gina Columbus

Articles by Gina Columbus

Eltrombopag Approved For Frontline Treatment of Severe Aplastic Anemia

Published: | Updated:

The approval of&nbsp;eltrombopag (Promacta) in combination with standard immunosuppressive therapy has been expanded by the FDA to include&nbsp;newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia, according to Novartis, the manufacturer of eltrombopag.<sup>&nbsp;</sup>Eltrombopag was also granted a breakthrough therapy designation&nbsp;as a counter measure for hematopoietic sub-syndrome of acute radiation syndrome.

CD8-Tracer Is Safe, Shows Biodistribution of T Cells in Tumors

Published: | Updated:

The CD8-tracer 89Zr-IAB22M2C, an anti-CD8 radiolabeled minibody, was found to be safe, well-tolerated, and demonstrated whole-body biodistribution of CD8-positive T cells in tumors and reference tissues, according to first-in-human results presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer.

Pegfilgrastim Biosimilar Approved by FDA

Published: | Updated:

Pegfilgrastim-cbqv (CHS-1701; Udencya), a pegfilgrastim (Neulasta) biosimilar, has been granted approval by the FDA&nbsp;for patients with cancer receiving myelosuppressive chemotherapy.

OS Benefit Seen in Nonsquamous NSCLC With Triplet Regimen in IMpower130

Published: | Updated:

Results from the phase III IMpower130 trial demonstrated a statistically significant improvement in both progression-free survival and overall survival with a triplet regimen of&nbsp;atezolizumab, carboplatin, and nab-paclitaxel compared with chemotherapy alone in patients with previously untreated stage IV nonsquamous non&ndash;small cell lung cancer.

Immunotherapy/TKI Combo Induces Favorable Findings in First-Line RCC

Published: | Updated:

A combination of an immune checkpoint inhibitor and a VEGF inhibitor, avelumab and axitinib, induced 2-fold higher&nbsp;objective response rates compared with&nbsp;sunitinib in patients with treatment-na&iuml;ve advanced renal cell carcinoma, regardless of their PD-L1 expression.&nbsp;Progression-free survival was also significantly improved over sunitinib, according to findings from the phase III JAVELIN Renal 101 trial presented at the 2018 ESMO Congress.

PALOMA-3 Analysis Finds Improved OS in Pretreated HR+/HER2- Breast Cancer

Published: | Updated:

In results from an analysis of the phase III&nbsp;PALOMA-3 trial, patients&nbsp;with hormone receptor-positive, HER2-negative advanced breast cancer who had progressed or relapsed on prior endocrine therapy achieved a clinically meaningful benefit in overall survival from&nbsp;the combination of palbociclib plus fulvestrant.&nbsp;

The combination of atezolizumab and nab-paclitaxel demonstrated a 2.5-month benefit in progression-free survival over nab-paclitaxel alone in&nbsp;patients with PD-L1&ndash;positive metastatic triple-negative breast cancer, according to findings of the phase III IMpassion130 trial presented at the 2018 ESMO Congress.

Overall Survival Not Improved With Nivolumab in SCLC

Published: | Updated:

According to topline findings, the phase III CheckMate-331 trial of nivolumab monotherapy for patients with small cell lung cancer who relapsed following platinum-based chemotherapy failed to meet its primary endpoint of improved overall survival compared with the standard topotecan or amrubicin.

LOXO-292 has been granted a breakthrough therapy designation by the FDA&nbsp;for treatment of patients with advanced RET fusion&ndash;positive thyroid cancer requiring systemic therapy, who have progressed on prior treatment and have no other acceptable alternative treatment options. Loxo Oncology, the developer of the selective RET inhibitor, released the news of the designation in a statement today.

Further advancements in precision medicine for patients with non&ndash;small cell lung cancer necessitate the use of more umbrella trials to evaluate therapies based on molecular aberrations versus tumor types, Vassiliki A. Papadimitrakopoulou, MD, suggested during a presentation at the <em>19th Annual </em>International Lung Cancer Congress.

Mitsudomi Explains the Best Sequencing Strategies for EGFR+ NSCLC

Published: | Updated:

In a presentation at the&nbsp;<em>19th Annual</em> International Lung Cancer Congress,&nbsp;Tetsuya Mitsudomi, MD, PhD, provided sequencing options to utilize the many available regimens for the best potential survival outcomes for patients with&nbsp;<em>EGFR</em>-mutant non&ndash;small cell lung cancer.

Immunotherapy Requires Precision Approach for NSCLC

Published: | Updated:

Several biomarkers are beginning to emerge for immunotherapy in non&ndash;small cell lung cancer, and the collection of these markers, when used together, could further help to predict which patients are likely to respond to these therapies alone or in combination, according to a presentation by Giorgio Scagliotti, MD, PhD, at the <em>19th Annual</em> International Lung Cancer Congress.

Despite recommendations from the United States Preventative Services Task Force, 1.9% of the 7.6 million current and former heavy smokers underwent cancer screening in 2016, suggesting screening is still inadequate. These results were presented ahead of the 2018 ASCO Annual Meeting being held in Chicago, Illinois on June 1-5, 2018.

According to results of a pilot study presented at the 2018 AACR Annual Meeting and simultaneously published in the <em>New England Journal of Medicine,</em>&nbsp;neoadjuvant treatment with the PD-1 inhibitor nivolumab (Opdivo) demonstrated a 45% major pathologic response rate in patients with resectable stage I to III non&ndash;small cell lung cancer (NSCLC) irrespective of PD-L1 expression.

Experts within the lung cancer community are eagerly anticipating the phase III findings of the KEYNOTE-189 trial, and they are hopeful that the combination of pembrolizumab (Keytruda) plus carboplatin and pemetrexed (Alimta) will demonstrate an overall survival advantage in patients with nonsquamous non&ndash;small cell lung cancer.

Lung Cancer is the Model for Precision Medicine, Expert Says

Published: | Updated:

In a presentation at the&nbsp;35th annual CFS, Edward S. Kim, MD, discussed the &quot;renaissance&quot; in the&nbsp;non&ndash;small cell lung cancer landscape that has come with the rapid evolution of targeted treatment for patients with&nbsp;<em>EGFR</em>-mutation&ndash;positive disease.