Conditions

This post was originally published on this site The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Cleveland Diagnostics’ IsoPSA, a minimally invasive blood test for early detection of prostate cancer. The IsoPSA test works by identifying cancer-related structural changes in a key protein. The breakthrough device designation is awarded to…

This post was originally published on this site Daiichi Sankyo has submitted an application to Japanese regulatory authorities asking that its investigational therapy trastuzumab deruxtecan (DS-8201) be approved as a treatment for people with HER2-positive metastatic breast cancer. The New Drug Application (NDA) is based on results from the multi-center, randomized, open-label DESTINY-Breast01 Phase 2…

This post was originally published on this site The Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA), has recommended that two regimens of Keytruda (pembrolizumab) be approved in Europe for first-line treatment of metastatic or inoperable recurrent head and neck squamous cell carcinoma (HNSCC). The CHMP recommends that…

This post was originally published on this site A Phase 2 clinical trial is recruiting patients with untreated follicular lymphoma — the most common type of non-Hodgkin’s lymphoma — to study a combination of Aliqopa (copanlisib) and rituximab. The trial (NCT03789240) will be conducted at the National Institutes of Health Clinical Center, in Maryland, under the leadership…

This post was originally published on this site Men with prostate cancer who undergo surgery have similar long-term outcomes whether they receive radiation therapy shortly after the surgery or only when signs of disease recurrence appear, suggesting that some may be spared the radiation treatment, a Phase 3 clinical trial shows. Findings from the trial…

This post was originally published on this site Bempegaldesleukin (bempeg, NKTR-214) in combination with Opdivo (nivolumab) leads to prolonged treatment responses in women with advanced or metastatic triple-negative breast cancer (TNBC), a Phase 1/2 trial shows. The findings were presented in a poster titled, “Clinical activity of BEMPEG plus NIVO observed in metastatic TNBC: preliminary…

This post was originally published on this site Blincyto (blinatumomab) increases overall survival and disease-free survival in children and adolescents with B-cell acute lymphoblastic leukemia (ALL) who already had their first relapse, data from Phase 3 trials show. Blincyto, developed by Amgen, is an antibody that binds to CD19, a protein found on the surface of…

This post was originally published on this site MEI Pharma’s experimental compound ME-401 reduced tumor burden in 78% of patients with relapsed or refractory follicular lymphoma and in 89% of those with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in an ongoing Phase 1b trial, the company announced. Responses were durable, updated…

This post was originally published on this site The European Medicines Agency (EMA) has recommended that Darzalex (daratumumab) be approved in Europe, in combination with Revlimid (lenalidomide) and dexamethasone, as a first-line treatment for multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT). Janssen announced the positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on…

This post was originally published on this site The U.S. Food and Drug Administration (FDA) has approved Zejula (niraparib) as a late-line treatment for women with advanced ovarian, fallopian tube, or primary peritoneal cancer who have tumors defective in DNA repair, a status termed “homologous recombination deficiency” (HRD), and have received at least three prior courses of…