A potential CAR T-cell therapy by Innovative Cellular Therapeutics (ICT) showed early signs of safety and efficacy, significantly reducing tumor size in four patients with thyroid or colorectal cancer, new data show. These findings will be shared in two presentations this Friday, May 15, at the ongoing 23rd American Society of Gene & Cell Therapy Annual…
Conditions
Conditions
FDA Approves Lynparza Combo as First-line Maintenance Therapy for Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has approved Lynparza (olaparib), in combination with bevacizumab, as a first-line maintenance therapy for women with advanced ovarian cancer positive for homologous recombination deficiency (HRD) and who responded to platinum-based chemotherapy. This indication also includes patients who have advanced fallopian tube or primary peritoneal cancer. HRD-positive tumors — present in one of every two women with advanced ovarian…
Zejula-Avastin Combo Treating Advanced Cancer Patients in Phase 2 Trial
Zejula (niraparib) given in combination with Avastin (bevacizumab) shows promising safety and efficacy at delaying disease progression in women with advanced ovarian cancer who had responded to a first-line platinum-based chemotherapy plus Avastin, interim results from a Phase 2 trial show. These findings are in the presentation, “Phase II OVARIO study of niraparib + bevacizumab therapy…
Tukysa Approved as Combo Therapy for Metastatic HER2-positive Breast Cancer in Switzerland
The Swiss Agency for Therapeutic Products (Swissmedic) has approved Seattle Genetics‘ Tukysa, in combination with trastuzumab and Xeloda (capecitabine), for the treatment of patients with metastatic HER2-positive breast cancer. Tukysa is now approved for individuals who have been treated previously with at least two other anti-HER2 therapies, examples of which include Kadcycla (ado-trastuzumab emtansine), Perjeta (pertuzumab), and trastuzumab (sold under the brand name Herceptin,…
Erleada Add-on Significantly Extends Survival in Non-metastatic CRPC, SPARTAN Analysis Shows
Adding Erleada (apalutamide) to androgen deprivation therapy (ADT) significantly extends the lives of men with non-metastatic castration-resistant prostate cancer (CRPC) by more than one year, a final analysis of the SPARTAN Phase 3 clinical trial shows. Representing a 22% reduction in the risk of death in men at high risk of developing metastasis, the findings add…
FDA Asks for More Data on Ide-cel as Potential Multiple Myeloma Therapy
The U.S. Food and Drug Administration (FDA) asked for more information from Bristol Myers Squibb and Bluebird Bio as it considers a request to approve their lead CAR T-cell therapy — idecabtagene vicleucel (ide-cel; bb2121) — for heavily pre-treated patients with multiple myeloma. The agency’s refusal letter requested further details on the potential therapy’s chemistry, manufacturing and control — or…
PTI-125 Fails to Lower Alzheimer’s Protein Levels in Phase 2 Trial
Cassava Sciences‘s investigational therapy PTI-125 failed to significantly lower the levels of Alzheimer’s-relevant biomarkers present in fluid surrounding the brain and spinal cord of patients, according to results from a Phase 2b clinical trial. The company announced it will study these topline data in deciding next steps for PTI-125 as a potential treatment. Alzheimer’s disease…
Adcetris Plus Chemo Now First-line Treatment of Adults with sALCL in Europe
The European Commission (EC) has approved Adcetris (brentuximab vedotin) when used alongside chemotherapy as a first treatment for adults with systemic anaplastic large cell lymphoma (sALCL), a type of peripheral T-cell lymphoma (PTCL). The decision to extend Adcetris’ current approval came after the Committee for Medicinal Products for Human Use (CHMP), a branch of the European…
FDA Approves Opdivo-Yervoy Combo for First-line Treatment of Advanced NSCLC
The U.S. Food and Drug Administration (FDA) has approved a combination of Opdivo (nivolumab) with low-dose Yervoy (ipilimumab) for the initial treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors produce the PD-L1 protein. The approval is for those without alterations in the EGFR or ALK genes, and comes on the heels of promising…
SOLO-2 Results: Maintenance Therapy with Lynparza Extends Survival in Relapsed Ovarian Cancer
Maintenance therapy with AstraZeneca’s Lynparza (olaparib) extended survival by more than one year in women with BRCA-mutated relapsed ovarian cancer, whose tumors responded to platinum-based chemotherapy, final results from the SOLO-2 Phase 3 clinical trial show. Trial findings, “Final overall survival (OS) results from SOLO2/ENGOT-ov21: A phase III trial assessing maintenance olaparib in patients (pts)…
FDA Approves Tecentriq as Initial Treatment for Advanced NSCLC
The U.S. Food and Drug Administration (FDA) has approved Genentech‘s Tecentriq (atezolizumab) as an initial treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors produce high levels of the PD-L1 protein but have no alterations in the EGFR or ALK genes. Approval was based on findings from the IMpower110 Phase 3 trial (NCT02409342), which showed…
Gene Signature Can Predict Breast Cancer Responsiveness to New Class of Drugs, Scientists Say
Scientists have discovered a gene signature in certain types of breast cancer that can be used to determine the likelihood of these tumors responding to treatment with a new class of anti-cancer medications known as Smac-mimetics. Triple-negative breast cancer (TNBC) was one of the best responders, suggesting these agents may be adopted as a new…