This post was originally published on this site The time to disease worsening or death usually shortens with each additional line of therapy, but that does not seem to be the case when the Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) is used in people with mantle cell lymphoma (MCL), researchers found. A pooled analysis of…
Category: <span>Blog</span>
PharmaMar Asks FDA for Accelerated Approval of Lurbinectedin to Treat Relapsed SCLC
This post was originally published on this site PharmaMar is asking the U.S. Food and Drug Administration (FDA) to approve lurbinectedin (PM1183) to treat those with small cell lung cancer (SCLC) whose disease progressed following platinum-based chemotherapy. The new drug application (NDA) requesting accelerated approval for lurbinectedin was based on data from a multicenter, open-label Phase 2 trial…
Cure Alzheimer’s Fund Reaches $100 Million Milestone
This post was originally published on this site In awarding more than $100 million to support scientific efforts to prevent, slow or reverse Alzheimer’s disease, the nonprofit Cure Alzheimer’s Fund has reached a significant milestone. Since its founding, the 15-year-old organization has backed some 425 novel projects conducted by 170 investigators worldwide. Those projects have resulted…
FDA Expands Xtandi Approval to Include Metastatic Castration-sensitive Prostate Cancers
This post was originally published on this site The U.S. Food and Drug Administration (FDA) has agreed to expand Xtandi‘s (enzalutamide) approval to include men whose metastatic prostate cancer still responds to hormone therapy, Astellas Pharma and Pfizer, the treatment’s developers, announced. The recent approval, which covers men with metastatic castration-sensitive prostate cancer (mCSPC), follows approvals for non-metastatic and…
Pivotal Trial of Mirvetuximab Soravtansine in Advanced Ovarian Cancer Levels Likely in 2020
This post was originally published on this site ImmunoGen is planning to open an open-label, pivotal clinical trial of mirvetuximab soravtansine in platinum-resistant ovarian cancer patients with high levels of the folate receptor alpha (FRα) protein early next year, the company announced. Results could lead to the treatment’s accelerated, and conditional, approval by the U.S. Food and…
CHMP Recommends EU Approval of Darzalex Combo as First-line Treatment for Transplant-eligible Myeloma Patients
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…
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…
Troriluzole Shows Potential to Treat Moderate Alzheimer’s in Phase 2/3 Trial, Monitoring Board Rules
This post was originally published on this site Troriluzole, an investigational oral therapy by Biohaven, shows a potential to improve cognition and lessen brain volume loss, a sign of Alzheimer’s disease progression, a board reviewing the ongoing Phase 2/3 trial decided. The trial successfully completed its interim futility analysis — meaning it can efficiently reach preset…









