Boehringer Ingelheim has acquired all shares of ViraTherapeutics, a biopharmaceutical company specializing in the development of oncolytic viral therapies.
The European Commission has approved the Novartis agent Kymriah (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Bristol-Myers Squibb Co. said FDA accepted its supplemental Biologics License Application for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
Rafael Pharmaceuticals Inc. said FDA has granted an orphan drug designation to CPI-613, the company's lead Altered Energy Metabolism Directed drug candidate, for the treatment of peripheral T-cell lymphoma.
Aslan Pharmaceuticals said FDA has granted ASLAN003 Orphan Drug Designation as a treatment for acute myeloid leukemia.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the FDA approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia.
FDA approved lenvatinib capsules (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma.
Eisai and Merck said the European Commission granted a marketing authorization for the oral receptor tyrosine kinase inhibitor Lenvima (lenvatinib), as a single agent for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapy.
FDA approved pembrolizumab (Keytruda) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.
FDA has updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. FDA approved two different companion diagnostic tests, one for use with Keytruda and one for use with Tecentriq, as described below.
