Seattle Genetics Inc. said it has submitted a supplemental Biologics License Application to FDA based on data from the phase III ECHELON-1 trial evaluating Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma.
FDA has approved Yescarta (axicabtagene ciloleucel), a genetically modified cell therapy, to treat adult patients with certain types of large B cell lymphoma who have not responded to or have relapsed after at least two other kinds of treatment.
AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, said the FDA has granted accelerated approval to Calquence (acalabrutinib, previously known as ACP-196), a kinase inhibitor, for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
Scientists from within the industry, academia, and two U.S. national laboratories are working to streamline the process for development of cancer drugs. They are creating an open and sharable platform that integrates high-performance computing, shared biological data from public and industry sources, and emerging biotechnologies to dramatically accelerate the discovery.
Genentech announced FDA has accepted the company's supplemental Biologics License Application for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of advanced ovarian cancer.
Immune Design said the European Medicines Agency has granted Orphan Drug Designation for G100 for the treatment of follicular non-Hodgkin's lymphoma. G100 has also been granted orphan drug designation by the FDA for the treatment of follicular non-Hodgkin's lymphoma.
Bristol-Myers Squibb Co. said FDA has accepted for priority review its supplemental Biologics License Application for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.
Eli Lilly and Co. said FDA has granted Priority Review designation for its New Drug Application for Verzenio (abemaciclib), a cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
Boehringer Ingelheim said the supplemental New Drug Application for Gilotrif (afatinib) has been accepted for filing and granted Priority Review by FDA. The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 21 (L861Q), G719X, or S768I substitution mutations as detected by an FDA-approved test.
Janssen Biotech Inc. said it has submitted a New Drug Application to the FDA for apalutamide, an investigational, next generation oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer. Currently, there are no FDA approved treatments for patients with non-metastatic CRPC.
