AMGEN and Allergan plc submitted a Marketing Authorization Application to the European Medicines Agency for ABP 215, a biosimilar candidate to Avastin (bevacizumab). The companies said they this submission is the first bevacizumab biosimilar application submitted to the EMA. ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 monoclonal antibody that binds […]
ABBVIE said the European Commission granted conditional marketing authorization for Venclyxto (venetoclax) monotherapy for the treatment of chronic lymphocytic leukaemia in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p […]
Genentech, a member of the Roche Group said the FDA has granted full approval for Avastin (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy.
FDA approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of renal cell carcinoma returning after nephrectomy.
FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene.
Tesaro Inc. said the European Commission has granted marketing authorization for Zejula (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.
G1 Therapeutics Inc. and AstraZeneca announced a collaboration to evaluate AstraZeneca's epidermal growth factor receptor tyrosine kinase inhibitor Tagrisso (osimertinib) in combination with G1's oral CDK4/6 inhibitor G1T38 for the treatment of EGFR mutation-positive non-small cell lung cancer.
ITUS Corp. said it has entered into a Cooperative Research and Development Agreement with Moffitt Cancer Center, to advance toward human clinical testing, a Chimeric Antigen Receptor T-Cell technology aimed initially at ovarian cancer, and eventually additional solid tumors.
FDA approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of renal cell carcinoma returning after nephrectomy.
FDA granted a regular approval to obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma.
