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.
PDS Biotechnology signed an Cooperative Research and Development Agreement with NCI to co-develop several immunotherapies through phase II clinical trials to be initiated in 2016 and 2017, utilizing combinations of PDS’s Versamune with NCI- and PDS-sourced tumor-related proteins or their antigens in prostate, breast, and HPV-related cancers. The PDS-NCI CRADA collaboration is led by Jay... […]
FDA granted orphan drug status to tazemetostat, an EZH2 inhibitor developed by Epizyme Inc., for malignant rhabdoid tumors.
FDA granted orphan drug designation to antifungal drug candidate CD101 IV, developed by Cidara Therapeutics Inc., for the treatment of candidemia and invasive candidiasis. The seven-year period of marketing exclusivity provided through orphan designation combined with an additional five years of marketing exclusivity provided from the previously announced QIDP designation gives CD101 IV for a... […]
The Mayo Clinic in Jacksonville, Fla. will collaborate with Morphotek Inc., a subsidiary of Eisai Inc., in a clinical study in patients with folate receptor alpha positive, triple-negative breast cancer.
FDA issued a complete response letter to a Biologics License Application submitted by Telesta Therapeutics Inc. for MCNA. FDA said that additional phase III clinical trial for MCNA would be necessary to adequately establish MCNA's efficacy and safety.
Venetoclax received its third Breakthrough Therapy Designation from the FDA, for a combination treatment with hypomethylating agents for patients with untreated acute myeloid leukemia who are ineligible to receive standard induction therapy.
