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.
FDA granted accelerated approval to a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.
FDA approved Zepatier (elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus genotype 1 or 4 infection, with or without ribavirin, following priority review.
FDA approved Halaven (eribulin mesylate) Injection for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen, following priority review.
FDA granted accelerated approval to a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.
FDA granted a Breakthrough Therapy Designation to venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia.
FDA granted Priority Review to lenvatinib for the treatment of patients with unresectable advanced or metastatic renal cell carcinoma in combination with everolimus following one prior vascular endothelial growth factor-targeted therapy. FDA previously granted lenvatinib Breakthrough Therapy designation for this investigational indication. “With the FDA’s acceptance of this supplemental application, we are one step closer... […]
Debiopharm International SA announced a collaboration in order to supply triptorelin pamoate 3.75 mg one-month formulation for patients suffering from salivary gland cancer participating in a clinical study sponsored by the European Organisation for Research and Treatment of Cancer.
