Lenvima (lenvatinib) launched in the U.K. as a treatment option for adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Janssen Research & Development initiated the rolling submission of its Biologic License Application for daratumumab to FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a PI and an IMiD.
Lenvima (lenvatinib) launched in the U.K. as a treatment option for adult patients with progressive locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
MD Anderson Cancer Center and Nektar Therapeutics announced a research collaboration that includes a phase I/II clinical study to evaluate NKTR-214, a CD122-biased cytokine designed to preferentially stimulate production of CD8-positive T cells.
FDA granted an orphan drug designation for APTO-253 for the treatment of acute myeloid leukemia.
Merck Canada Inc. announced that Keytruda (pembrolizumab) was authorized for sale with conditions by Health Canada.
FDA granted an Orphan Drug Designation to Reolysin for the treatment of malignant glioma.
The European Commission approved Aloxi (palonosetron HCl) injection for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, in pediatric patients one month of age and older.
Halozyme Therapeutics Inc. and Ventana Medical Systems Inc., a member of the Roche Group, will collaborate and develop a Ventana companion diagnostic assay for use with Halozyme's investigational new drug PEGPH20.
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending a change to the terms of the marketing authorization for Imbruvica (ibrutinib) in the European Union to indicate the treatment of adult patients with Waldenström's macroglobulinemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
