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Lynparza Approved in Japan to Treat Certain Advanced Ovarian Cancers

Lynparza Approved in Japan to Treat Certain Advanced Ovarian Cancers

Lynparza (olaparib) has been approved in Japan as a maintenance treatment for women with advanced ovarian cancer who responded to a first-line chemotherapy regimen containing bevacizumab, AstraZeneca and Merck announced in a press release. The approval, for patients whose cancer is positive for homologous recombination deficiency (HRD), is based on data from the PAOLA-1 Phase 3 trial (NCT02477644),…

Orgovyx Now Available in US for Advanced Prostate Cancer

Orgovyx Now Available in US for Advanced Prostate Cancer

A couple of weeks after its approval, Orgovyx (relugolix) is now commercially available in the U.S. for adults with advanced prostate cancer through authorized specialty distributors, the therapy’s developer, Myovant Sciences, has announced. “Myovant has been focused on ensuring access to Orgovyx for men with advanced prostate cancer as quickly as possible following approval, and…

PT-112 Shows Promise for Heavily Treated Myeloma Patients

PT-112 Shows Promise for Heavily Treated Myeloma Patients

Phosplatin Therapeutics‘ investigational medication PT-112 showed promising efficacy and safety data in an early clinical trial of heavily-pretreated people with relapsed or refractory multiple myeloma. The findings were shared in a presentation, “A Phase I Dose Escalation Study of PT-112 in Patients with Relapsed or Refractory Multiple Myeloma,” at the 62nd American Society of Hematology (ASH)…

Donanemab Found to Slow Cognitive, Functional Decline in Early Alzheimer’s

Donanemab Found to Slow Cognitive, Functional Decline in Early Alzheimer’s

Donanemab (LY3002813), Eli Lilly’s experimental antibody-based immunotherapy, slowed cognitive and functional decline in patients at the earlier stages of Alzheimer’s disease, according to data from a Phase 2 trial. Findings from this trial, called TRAILBLAZER-ALZ (NCT03367403), also showed donanemab had a favorable safety profile, which was consistent with observations from previous clinical trials. “We are…

Genetic Test for Advanced Breast Cancer Launched in EU

Genetic Test for Advanced Breast Cancer Launched in EU

Roche has launched a diagnostic genetic test to detect mutations in the PIK3CA gene in patients with advanced or metastatic breast cancer in the European Union. The cobas PIK3CA mutation test, performed in the lab (in vitro) and previously available for research purposes only, is now available in countries accepting the CE mark. “We are pleased to…

GPS Vaccine-Keytruda Combo Showing Efficacy in Advanced Cancer Patients

GPS Vaccine-Keytruda Combo Showing Efficacy in Advanced Cancer Patients

Combining the experimental vaccine galinpepimut-S (GPS) with the immune checkpoint inhibitor Keytruda (pembrolizumab) induces promising responses in people with metastatic ovarian cancer who failed one or two prior lines of treatment, early data from a Phase 1/2 trial show. The combination kept all eight patients in a first evaluated group in the trial (NCT03761914) without signs…

Nubeqa Prescribing Information Updated With New Survival Data

Nubeqa Prescribing Information Updated With New Survival Data

The prescribing information for Nubeqa (darolutamide) — used to treat men with prostate cancer that has not spread to other parts of the body — will be updated to include overall survival data for patients with non-metastatic castration-resistant prostate cancer (nmCRPC), according to Bayer, one of the therapy’s developers. Specifically, data demonstrating that Nubeqa lowers…

T-cell Therapy Showing Promise in Synovial Sarcoma Patients in Phase 1 Trial

T-cell Therapy Showing Promise in Synovial Sarcoma Patients in Phase 1 Trial

ADP-A2M4, an investigational therapy that uses engineered immune cells to fight cancer, showed an acceptable safety profile and promising effectiveness in people with synovial sarcoma, a rare cancer that develops around the joints and tendons, new clinical trial data show. The findings were presented at the Connective Tissue Oncology Society (CTOS) annual meeting by trial…

First Patient Dosed in Phase 3 Trial Testing Melflufen Triple Combo

First Patient Dosed in Phase 3 Trial Testing Melflufen Triple Combo

The first participant has been dosed in a Phase 3 trial investigating a triple combination of melflufen (melphalan flufenamide) plus dexamethasone and under-the-skin Darzalex (daratumumab) in people with heavily treated multiple myeloma. The trial, dubbed LIGHTHOUSE (NCT04649060), had been delayed by the COVID-19 pandemic but is now recruiting an estimated 240 participants, ages 18 and…

Mindfulness Can Alter Brain’s Perception of Pain in Cancer Survivors

Mindfulness Can Alter Brain’s Perception of Pain in Cancer Survivors

Mindfulness can significantly improve brain health and pain perception in breast cancer survivors, according to a small Canadian study. The findings suggest that an eight-week mindfulness intervention can reduce activity in parts of the brain related to pain and to emotional reactivity (having a heightened emotional response to something unpleasant). The study, “Reduced Emotional Reactivity…

FDA Gives Orphan Drug Status to Potential  Multiple Myeloma Immunotherapy

FDA Gives Orphan Drug Status to Potential Multiple Myeloma Immunotherapy

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Harpoon Therapeutics‘ investigational immunotherapy HPN217 as a possible treatment of multiple myeloma. The designation encourages the development of potential therapies for rare and serious diseases by granting them various financial and regulatory benefits. These include exemptions from certain fees, trial protocol assistance, and seven years…

Axsome Launches AXS-05 Phase 3 Trial for Alzheimer’s-associated Agitation

Axsome Launches AXS-05 Phase 3 Trial for Alzheimer’s-associated Agitation

Axsome Therapeutics has launched a Phase 3 trial that will assess the safety and efficacy of AXS-05, the company’s investigational oral treatment for agitation associated with Alzheimer’s disease. If positive, data from the trial is expected to support Axsome’s submission of an application requesting the therapy’s approval for treating Alzheimer’s patients with agitation. According to…