Merck KGaA, Pfizer and Verastem entered into an agreement to evaluate avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Verastem’s VS-6063, an investigational focal adhesion kinase inhibitor, in patients with advanced ovarian cancer. Avelumab is currently under clinical investigation across a broad range of tumor types. The phase I/Ib clinical trial... […]
FDA and the European Medicines Agency have both granted Orphan Drug Designation to FLAG-003 for the treatment of glioma, sponsored by FLAG Therapeutics. Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases, those which affect fewer than 200,000 Americans annually. Orphan drug... […]
The European Medicines Agency granted an Orphan Drug Designation to venetoclax, an investigational, oral B-cell lymphoma-2 inhibitor, for the treatment of acute myeloid leukemia. Venetoclax is being developed by AbbVie in partnership with Genentech and Roche. The EMA previously granted Orphan Drug Designation to venetoclax for the treatment of chronic lymphocytic leukemia. Orphan Designation is... […]
FDA granted orphan drug designation to the WT1 cancer vaccine developed by SELLAS Life Sciences Group for the treatment of patients with malignant pleural mesothelioma. SELLAS recently reported positive results of a phase II trial of its WT1 vaccine in MPM patients, showing that overall survival improved and progression-free survival doubled. Based on these findings,... […]
Health Canada approved Opdivo injection (nivolumab), the first and only immuno-oncology therapy approved in Canada for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy. The approval was made under the Health Canada Priority Review process, after having met the criteria of substantial... […]
FDA approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia.
FDA approved Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment.
FDA granted Breakthrough Therapy designation to PKC412 (midostaurin), an investigational treatment for adults with newly-diagnosed AML who are FLT3 mutation-positive, as detected by an FDA-approved test, and who are eligible to receive standard induction and consolidation chemotherapy. The designation is primarily based upon results from the phase III RATIFY clinical trial. This study was conducted... […]
FDA approved Afinitor (everolimus), sponsored by Novartis, for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors of gastrointestinal or lung origin with unresectable, locally advanced or metastatic disease. The approval was based on demonstration of improvement in progression-free survival in a multicenter, randomized, placebo-controlled trial of everolimus 10 mg orally once daily... […]
FDA approved Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment.
