The Chinese regulatory agency has agreed to review Zai Lab‘s application asking that Zejula (niraparib) be approved as first-line maintenance therapy for women with ovarian cancer who are responding to platinum-based chemotherapy, the company announced. The supplemental New Drug Application (sNDA), submitted to the China National Medical Products Administration (NMPA), is for women with advanced epithelial…
A combination of Ninlaro (ixazomib), Revlimid (lenalidomide), and dexamethasone failed to significantly extend the time to disease progression or death in people with newly diagnosed multiple myeloma who are ineligible for stem cell transplants, compared with Revlimid and dexamethasone alone, results from a Phase 3 trial show. The combination did help patients live 13.5 months longer…
This post was originally published on this site The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Seattle Genetics’ tucatinib, in combination with trastuzumab and Xeloda (capecitabine), for the treatment of patients with locally advanced inoperable or metastatic HER2-positive breast cancer. The designation, which also includes those with brain metastases, is…
This post was originally published on this site Lynparza (olaparib), a breast and ovarian cancer treatment, is also showing promising results in men with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in DNA repair genes, particularly the BRCA1 and BRCA2 genes, according to data from a Phase 2 study. The study’s final data, “Olaparib in patients…
This post was originally published on this site Aravive is recruiting participants for a Phase 1/2 clinical trial assessing a combination of its experimental treatment AVB-500 plus the immune checkpoint inhibitor Imfinzi (durvalumab) in women with platinum-resistant epithelial ovarian cancer. The trial (NCT04019288) is ongoing at the MD Anderson Cancer Center, in Texas, and is…
This post was originally published on this site For people with multiple myeloma who don’t respond well to an initial type of therapy, quickly switching to another type may improve clinical outcomes, a new study suggests. The study, “Response-adapted intensification with cyclophosphamide, bortezomib, and dexamethasone versus no intensification in patients with newly diagnosed multiple myeloma…
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…
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…
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…
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…
