News

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.

The FDA has granted LN-144, an adoptive cell therapy that uses tumor-infiltrating lymphocyte technology developed by Iovance Biotherapeutics, a fast track designation for the treatment of patients with advanced melanoma.

A look at some of the major developments in the chimeric antigen receptor T (CAR-T) cell space.

The FDA has approved the first gene therapy available in the United States, tisagenlecleucel (Kymriah), for the treatment of pediatric and young adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

A gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), a rare skin disease that causes the skin to be very fragile and blister easily, has been granted Breakthrough Therapy designation status by the FDA.

Novartis’ just-approved chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel is going to be introduced on the market at a price of $475,000 for a single infusion, an amount that is within the range anticipated by oncologists.

The FDA issued a historic approval of the first chimeric antigen receptor (CAR) T-cell therapy, authorizing the use of tisagenlecleucel (Kymriah) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.

The FDA has approved the first chimeric antigen receptor-T (CAR-T) treatment, tisagenlecleucel (Kymriah), for the treatment of B-cell precursor acute lymphoblastic leukemia in certain pediatric and young adult patients. The therapy represents a new frontier in cancer care.

Gilead Sciences will acquire Kite Pharma by the end of 2017 in an $11.9 billion transaction that will place Gilead at the forefront of chimeric antigen receptor-T (CAR-T) cell therapy development.

Despite all the excitement and anticipation, there is a growing anxiety among payers and providers regarding the cost of CAR T cells.

Chimeric antigen receptor (CAR)-T cells can re-expand in a lymphoma patient months after the initial infusion and can also be active against the patient’s cancer, according to a new study.

Shaji Kumar, MD, discusses his ixazomib maintenance trial, the latest FDA activity in myeloma, and the potential of chimeric antigen receptor (CAR) T-cell therapy in the field of myeloma.

Chimeric antigen receptor (CAR) T-cell therapies could spawn a new and lucrative industry in anticancer immunotherapy, resulting in single-infusion treatments costing hundreds of thousands of dollars, and even attracting medical tourism from abroad, where regulatory permissions are likely to come more slowly than in the United States.

Patients with newly diagnosed multiple myeloma treated with lenalidomide maintenance therapy after undergoing autologous stem-cell transplantation had significantly improved overall survival compared with observation or placebo.

Researchers have determined that CD30-specific CAR T cells could be used safely and induce durable complete responses in patients with Hodgkin lymphoma and anaplastic large cell lymphoma.

Companies are skirting regulation to be the first to build the next big stem cell therapy, creating clinical concerns and poor patient outcomes.

The Institute for Clinical and Economic Review (ICER) has released a draft version of their scoping document that will compare the clinical effectiveness and value of 2 chimeric antigen receptor (CAR)-T cell treatments being reviewed by the FDA.

A biomarker for pancreatic precursor cells might give researchers a shortcut to create insulin-producing beta cells that can be transplanted into patients with type 1 diabetes.

Surgical management of the patient with non–small-cell lung cancer (NSCLC) is complex. When should stereotactic body radiation therapy be used? What are the advantages of video-assisted thoracic surgery? Test your knowledge in our latest quiz.

There’s a lot happening in clinical practice with immunotherapy treatments: expanded indications for nivolumab and ipilimumab, biomarkers to judge patient response to combinations, and developments with CAR-T.

Acalabrutinib has been granted FDA Breakthrough Therapy Designation for the treatment of patients with mantle cell lymphoma who have relapsed or have received at least one prior therapy.

The new immunotherapy of chimeric antigen receptor (CAR)-T cells has demonstrated the ability to increase clinical remission in multiple myeloma patients by targeting the B-cell maturation protein that participates in disease progression.

The FDA has granted acalabrutinib a breakthrough therapy designation for patients with previously-treated mantle cell lymphoma.

Saad Z. Usmani, MD, discusses recent multiple myeloma data, the potential role of CAR T-cell therapy, and what therapeutic advancements the community can expect in the remainder of 2017.