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Evidence-Based OncologyTM sat down with Brandon R. Shank, PharmD, MPH, BCOP, clinical pharmacy specialist, Division of Pharmacy, The University of Texas MD Anderson Cancer Center, to understand a pharmacist's role in administering chimeric antigen receptor (CAR) T cells.

An advisory committee gave unanimous support to Luxturna, 3 months prior to its BLA ruling.

The second-generation EGFR tyrosine kinase inhibitor dacomitinib significantly improved progression-free survival over gefitinib as a first-line therapy for EGFR–positive non–small-cell lung cancer, according to a randomized phase III trial.

Defined composition CAR T cells directed against CD19 have potent anti-tumor activity in B cell malignancies, including acute lymphocytic leukemia.

The FDA has awarded Breakthrough Therapy Designation to osimertinib for first-line treatment of patients with metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC).

A new therapy has succeeded in restoring leg function in mouse models, though the researchers say it will be years before such a therapy can be tried in humans.

Adjuvant therapy with tyrosine kinase inhibitors for patients with high-risk renal cell carcinoma (RCC) who have undergone a nephrectomy may be supported by level IIa evidence from the National Comprehensive Cancer Network guidelines.

Chimeric antigen receptor T-cell therapy for hematological malignancies took a huge step forward this summer with the FDA approval of Novartis

Maintenance therapy with rituximab following autologous stem cell transplantation prolonged progression-free, event-free, and overall survival compared with observation in patients with mantle cell lymphoma, according to a new study.

While the FDA’s approval of the immunotherapy tisagenlecleucel represents a landmark in the oncology field, the treatment is far from being a cure and should be viewed in context of its $475,000 price tag, a group of oncologists wrote in a commentary published in JAMA.

When immune-related adverse events arise from nivolumab, it may indicate that the therapy is having greater efficacy against non—small-cell lung cancer (NSCLC), as a new study demonstrates a link between these events and improved survival outcomes.

Treatment with the autologous anti-CD19 CAR T-cell therapy axicabtagene ciloleucel significantly improved outcomes in refractory non-Hodgkin lymphoma compared with standard therapies.

Chimeric antigen receptor T-cell therapy may soon hit the market, and numerous cancer care centers are poised to offer this for what may be the first FDA-approved indication: relapsed/refractory B-cell acute lymphoblastic leukemia.

Patients with refractory chronic lymphocytic leukemia achieved a high-response rate with CD19-targeted CAR T-cell therapy JCAR014.

Physicians across different institutes who have been involved in clinical trials of chimeric antigen receptor (CAR) T cells in B-cell lymphomas have developed a guideline for monitoring and managing the symptoms associated with this treatment.

The FDA’s Oncologic Drugs Advisory Committee voted 6-6 on the potential approval of sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are at high risk of recurrence.

Patients who received maintenance therapy with rituximab (Rituxan) following autologous stem cell transplantation as treatment for mantle cell lymphoma had a survival advantage, according to results from a retrospective single-center study.

James L. Ferrara, MD, discusses the significance of the FDA approving tisagenlecleucel as the first CAR T-cell therapy.

Although anti-PD-1/PD-L1 immunotherapy has greatly improved the treatment of patients with non–small cell lung cancer and is generally well-tolerated, the therapy backfires in a newly defined subset of patients who experience accelerated tumor growth indicative of hyperprogressive disease.

After CMS and Novartis devised an outcomes-based payment approach for the new chimeric antigen receptor (CAR)-T treatment tisagenlecleucel (Kymriah), a group of representatives are requesting more information on the specifics of the agreement.

Pembrolizumab (Keytruda) reduced the risk of death compared with standard of care therapy in patients with relapsed/metastatic head and neck squamous cell carcinoma, but the difference fell just shy of statistical significance.

High-intensity local radiation combined with systemic therapy improved overall survival compared with systemic therapy alone in patients with head and neck squamous cell carcinoma.

Treating primary tumors by administering targeted therapy with sunitinib (Sutent) prior to cytoreductive nephrectomy did not improve the progression-free rate at 28 weeks over a sequence of immediate CN followed by sunitinib in patients with synchronous metastatic renal cell carcinoma.

Patients with untreated advanced renal cell carcinoma lived significantly longer without disease progression when they received the multikinase inhibitor cabozantinib (Cabometyx) as initial therapy versus sunitinib (Sutent).

Frontline osimertinib improved median progression-free survival by 18.9 months, representing a 54% reduction in the risk of progression or death compared with standard therapy for patients with EGFR-mutant non–small cell lung caner.

Anti-CD19 chimeric antigen receptor (CAR)-modified T-cell therapy was highly effective in patients with high-risk chronic lymphocytic leukemia who had previously failed treatment with ibrutinib.

The FDA has granted a breakthrough therapy designation to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC.

The FDA placed clinical holds on 2 phase I trials investigating a gene-edited allogeneic CAR T-cell (UCART) therapy known as UCART123.

Cellectis, a clinical-stage biotechnology company, was asked by the FDA to place a clinical hold on 2 phase 1 trials evaluating its allogeneic chimeric antigen receptor-T (CAR-T) cell treatments following the report of a fatality in the first patient treated in one of the studies.