This post was originally published on this site The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Darzalex (daratumumab), in combination with standard pre-transplant therapy, for the treatment of newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant (ASCT). The recommendation, based on data from the CASSIOPEIA Phase 3 trial (NCT02541383), is for…
Category: Cancer
ATYR1923 Is Safe, Well-tolerated by Pulmonary Sarcoidosis Patients, Phase 1/2 Trial Shows
This post was originally published on this site ATYR1923, aTyr Pharma’s lead investigational therapy for pulmonary sarcoidosis, is safe and well-tolerated, according to interim data from a Phase 1b/2a clinical trial. ATYR1923 is a first-in-class disease-modifying therapy in development for the treatment of different types of interstitial lung diseases (ILDs), collectively characterized by progressive scarring (fibrosis)…
Adding BL-8040 to Keytruda and Chemo Shows Good Disease Control in Pancreatic Cancer, Phase 2 Trial Shows
This post was originally published on this site Treatment with investigational BL-8040, in combination with Keytruda (pembrolizumab) and chemotherapy, leads to promising response and disease control rates in people with metastatic pancreatic cancer who progressed after first-line therapy, preliminary data from a Phase 2a clinical trial show. The findings were revealed in an oral presentation,…
TAVO Boosts Responses to Keytruda in Triple-negative Breast Cancer Patients, Interim Phase 2 Data Show
This post was originally published on this site Treatment with TAVO (intratumoral IL-12) appears to increase the sensitivity of previously treated advanced triple-negative breast cancers (mTNBC) to the immune checkpoint inhibitor Keytruda (pembrolizumab), interim data from a Phase 2 study show. The results highlight TAVO’s potential in this hard-to-treat population, even in patients with PD-L1-negative…
Prostate Cancer Campaigns Boost Enrollment in Study to Validate ClarityDX Diagnostic Test in Canada
This post was originally published on this site Campaigns by Movember and the Alberta Cancer Foundation have helped to raise the number of men enrolled to more than 200 in the validation study of ClarityDX Prostate, a new blood screening test developed by Nanostics for the early diagnosis of prostate cancer. Recruitment, which started in June…
Meeting with FDA Supports Tazemetostat for Some Follicular Lymphoma
This post was originally published on this site Epizyme successfully met with the U.S. Food and Drug Administration (FDA) to bolster an upcoming submission of its oral investigational treatment tazemetostat for relapsed or resistant follicular lymphoma, with or without EZH2 activating mutations. The pre-New Drug Application (NDA) meeting is a critical step to ensure a…
Advanced Multiple Myeloma Patients Responding to Janssen’s CAR T-cell Therapy, Trial Data Show
This post was originally published on this site Janssen’s investigational CAR T-cell therapy for multiple myeloma, called JNJ-4528 (JNJ-68284528), safely led to early and deep responses in all patients with relapsed or refractory multiple myeloma treated in the first part of a Phase 1/2 trial. These findings were announced in the oral presentation, “Results from…
Breast Cancer Index Identifies Women Likely to Benefit From Extended Hormone Therapy, Latest Data Show
This post was originally published on this site The Breast Cancer Index, a molecular test developed by Biotheranostics, successfully identified a group of women with hormone receptor (HR)-positive breast cancer who may benefit from long-term hormone therapy with tamoxifen, data from a Phase 3 trial shows. Study findings were presented in a poster, titled “Breast…
Bemcentinib-Keytruda Combo Effective in Some Advanced NSCLC Patients with Poor Prognosis
This post was originally published on this site Combining bemcentinib with Keytruda (pembrolizumab) is effective and delays disease progression in people with previously treated advanced non-small cell lung cancer (NSCLC), particularly in those with AXL-positive tumors. Those updated results from a Phase 2 clinical trial show, to researchers’ surprise, that benefits also were seen in people with low levels of PD-L1…
NICE Recommends Lynparza Tablets for Relapsed, BRCA-mutated Advanced Ovarian Cancers
This post was originally published on this site After an initial rejection due to cost-effectiveness concerns, the U.K.’s National Institute of Health and Care Excellence (NICE) has reversed its decision and is expanding the use of Lynparza (olaparib) tablets to include maintenance therapy for relapsed ovarian cancer patients who responded to platinum-based chemotherapy. The recommendation is…