Debating the True Benefit of Adjuvant TKIs in High-Risk RCC
October 4th 2017Adjuvant 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.
Rituximab Maintenance Therapy Can Improve Outcomes in Mantle Cell Lymphoma
September 28th 2017Maintenance 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.
JAMA Commentary Urges Realistic View of New CAR T-Cell Cancer Therapy
September 25th 2017While 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.
Immune Adverse Events From Nivolumab Predict Better Survival With NSCLC
September 23rd 2017When 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.
Physicians Develop Guidelines to Manage CAR T-Cell Toxicity
September 20th 2017Physicians 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.
FDA Panel Splits on Adjuvant Sunitinib in High-Risk RCC
September 20th 2017The 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.
Maintenance Rituximab Post-ASCT Associated With Improved OS in MCL
September 19th 2017Patients 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.
Study Finds Hyperprogression After Immunotherapy in NSCLC Subset
September 14th 2017Although 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.
Representatives Probe CMS for Further Detail on New CAR-T Therapy Payment Agreement
September 14th 2017After 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.
Mixed Results for Pembrolizumab in Phase III HNSCC Study
September 13th 2017Pembrolizumab (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.
CABOSUN Update Affirms PFS Advantage With Cabozantinib Over Sunitinib in Advanced RCC
September 11th 2017Patients 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).
Companies Continue to Face Challenges With Developing CAR-T Treatment
September 5th 2017Cellectis, 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.
FDA Approves First Gene Therapy for Pediatric Leukemia
September 1st 2017The 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.
Abeona Receives Breakthrough Designation for Rare Skin Disease Gene Therapy
August 31st 2017A 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 Sets a Price of $475,000 for CAR T-Cell Therapy
August 31st 2017Novartis’ 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.
FDA OKs Tisagenlecleucel in ALL as First Approved CAR T-Cell Therapy
August 30th 2017The 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.