FDA Approves Prefilled Syringe for GEP-NETs Treatment
June 25th 2019The FDA has granted an approval to a prefilled syringe for lanreotide (Somatuline Depot), which has been designed to enable healthcare providers to administer the injection easier, for the treatment of adults with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.
FDA Approves Trastuzumab-Anns, a Herceptin Biosimilar
June 14th 2019The Food and Drug Administration (FDA) approved trastuzumab-anns (Kajinti), a biosimilar of trastuzumab (Herceptin) for the treatment of HER2-overexpressing breast cancer, metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA Approves Polatuzumab Vedotin for Relapsed, Refractory DLBCL
June 10th 2019The FDA has granted an accelerated approval to polatuzumab vedotin (Polivy) for use in combination with bendamustine and rituximab (Rituxan; BR) for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who have received at least 2 prior therapies.
Myeloma Treatment Landscape Continues to Change
June 2nd 2019Monoclonal antibodies, proteasome inhibitors, and targeted agents are among the many options in the crowded treatment landscape of relapsed/refractory multiple myeloma, and the emergence of drugs, such as venetoclax (Venclexta) and selinexor, could add to the complexity of this paradigm, said Cristina Gasparetto, MD.
FDA Grants Priority Review to Combination Regimen to Treat Multiple Myeloma
May 31st 2019The FDA granted a priority review to daratumumab (Darzalex) in combination with bortezomib (Velcade), thalidomide and dexamethasone (Vtd) for the front-line treatment of newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant.
New Therapies Are Coming for Lung Cancer With Rare Mutations
May 28th 2019In non–small cell lung cancer (NSCLC), KRAS G12 mutations have been historically difficult to target, and research efforts dedicated to the development of effective targeted therapies for NRG1 fusions have not been successful. However, several biopharmaceutical companies are in the early stages of addressing that challenge, explained Sai-Hong I. Ou, MD, PhD.
FDA Approves Alpelisib for Metastatic Breast Cancer
May 25th 2019The FDA has approved the PI3K inhibitor alpelisib (Piqray) for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.
FDA Approves New Therapy for Malignant Pleural Mesothelioma
May 24th 2019The FDA has approved the NovoTTF-100L System in combination with pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM), marking the first treatment for this patient population in more than 15 years.