This post was originally published on this site The U.S. Food and Drug Admnistration (FDA) has agreed to review Sanofi’s biologics license application (BLA) for its investigational antibody, isatuximab, as a potential therapy for patients with hard-to-treat multiple myeloma, the company announced. FDA’s final decision about whether to approve isatuximab is expected by April 30, 2020, according…
This post was originally published on this site I had my six-month checkup with the oncologist a couple of weeks ago. I won’t keep you in suspense: My follicular lymphoma is stable, and things look good. But it was a rough ride getting to the good news. Literally. I made the appointment for 9 a.m.…
This post was originally published on this site Dosing with the investigational therapy TP-0903 has begun in patients with previously treated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in an ongoing Phase 1/2 trial, its developer, Tolero Pharmaceuticals, announced. The open-label study (NCT03572634) aims to recruit 108 patients who have failed to respond to prior therapies.…
This post was originally published on this site Libtayo (cemiplimab) has been conditionally approved to be sold in the European Union for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), one of the most common types of skin cancer. The decision of the European Commission (EC) makes Libtayo the…
This post was originally published on this site A combination of Polyphor‘s investigational therapy balixafortide (POL6326) and Eisai‘s Halaven (eribulin) may prolong the survival of women with HER2-negative metastatic breast cancer, a Phase 1 trial shows. The findings were presented in the poster “Balixafortide (a CXCR4 antagonist) + eribulin in HER2-negative metastatic breast cancer (MBC): Survival…
This post was originally published on this site Advantagene, also known as Candel Therapeutics, has reached its patient enrollment goal in an ongoing Phase 2 trial testing the effectiveness of ProstAtak, the company’s prostate cancer vaccine, among men with localized prostate cancer who chose to remain on active surveillance. ProstAtack is a gene-mediated cytotoxic immunotherapy…
This post was originally published on this site After positive feedback from the U.S. Food and Drug Administration, TG Therapeutics is planning to pursue accelerated approval for umbralisib (TGR-1202) as a treatment for patients with marginal zone lymphoma (MZL). The decision was supported by findings from the ongoing UNITY-NHL Phase 2b clinical trial (NCT02793583), in which…
This post was originally published on this site A liquid biopsy assay called Resolution HRD is being used in Phase 2 and Phase 3 trials of Zejula (niraparib) to help screen key mutations in prostate cancer patients. Through a blood draw, Resolution Bioscience’s cell-free DNA (cfDNA) assay identifies mutations implicated in homologous recombination deficiency (HRD),…
This post was originally published on this site A combination of Zejula (niraparib) and Keytruda (pembrolizumab) is well-tolerated and has promising anti-tumor activity in women with ovarian carcinoma who have failed prior platinum-based chemotherapy, results from a Phase 1/2 trial show. Overall, 18% of the patients responded to the combo regimen, regardless of platinum resistance,…
This post was originally published on this site The U.S. Food and Drug Administration (FDA) has lifted its hold on the CANOVA Phase 3 clinical trial, which is evaluating the experimental therapeutic Vencexta (venetoclax) plus dexamethasone in people with relapsed or refractory multiple myeloma who test positive for a common genetic abnormality. Venclexta (sold as Venclyxto…
